Montefiore Medical Center, New York, United States
Background/Case Studies: Automated blood grouping and antibody testing systems are widely used in transfusion service laboratories to perform blood typing and antibody screening, and while they offer several advantages over manual testing, errors or unexpected performance may still occur. For antibody screening, false negative results can have serious consequences, including delayed diagnosis, transfusion reactions, and patient harm. Consequently, the reliability and accuracy of these systems are crucial to ensuring safe and suitable blood transfusion. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected malfunctions or injuries from device use. The Manufacturer and User Facility Device Experience (MAUDE) database, which serves as a repository for MDRs, is a valuable resource for post-market surveillance of medical devices, including automated blood grouping and antibody testing systems, and allows the FDA to identify potential safety issues and passively monitor device performance. However, limited information is available on the post-market prevalence of false negative results for these testing modalities and their associated clinical consequences. This study aims to analyze MDRs involving automated blood grouping and antibody testing systems with a reported false negative result to better understand the potential adverse patient complications and inform transfusion medicine practices.
Study
Design/Methods: We searched the MAUDE database using product code KSZ (Automated Blood Grouping and Antibody Testing Systems) and the Product Problem term "False Negative Result" for MDRs reported between 01/01/2019 and 01/01/2023.
Results/Findings: A total of 266 MDRs involving false-negative results were identified within the search interval, with 6 (2.3%) MDRs including details about specific adverse patient complications, including hemolysis, respiratory distress, fever, hyperbilirubinemia, and hematuria. The MDRs involved various manufacturers and vendors (Table 1). Conclusions: This study highlights the utility of monitoring and reporting false negative results in automated blood grouping and antibody testing systems to improve patient safety for transfusion services. The MAUDE database, despite its passive-surveillance limitations such as underreporting and potential biases, offers valuable insights for post-market surveillance of these systems. Further investigation and increased awareness of these events may contribute to improving the reliability and accuracy of these devices in blood bank laboratories.
Importance of research: False negative results from Blood Bank instrumentation can have serious consequences, including delayed diagnosis, transfusion reactions, and patient harm. Healthcare providers in Transfusion Medicine should remain vigilant and be aware of the utility of resources such as the MAUDE database in making informed decisions regarding these instruments, user facility validation and verification, and potential operational limitations.
