P‐IS‐1 | Automated Blood Grouping and Antibody Testing Systems: An Analysis of Medical Device Reports for False‐Negative Results

Le résumé fourni par la source

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. 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 January 1, 2019 and January 1, 2023. 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). TABLE 1. Summary of MAUDE medical device reports reporting false-negative results by manufacturer.

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