BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL A2

    MDR report key: 13867914 · Received March 23, 2022

    Report

    Report Number
    9610824-2022-00014
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 23, 2022
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952625
    PMA / PMN Number
    125207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR COMBINED INTITAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF BIOTESTCELL-A2 DURING MANUAL TESTING. SHE STATED THAT A PATIENT SAMPLE WITH A KNOWN COLD AGGLUTININ AND THE HEMOBIOSCIENCE CONTROL QC1 (BLOOD GROUP A RH NEGATIVE, NO ANTIBODIES) SHOWED THE FALSE POSITIVE REACTIONS. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE BIOTESTCELL-A2 FOR INVESTIGATIONAL TESTING NOR THE SPECIMENS THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. WHEN THE CUSTOMER ANNOUNCED THAT SHE WOLD PROVIDE HER COMPLAINT SAMPLE AND THE QC AFTER ALL, BOTH HAD ALREADY EXPIRED. THEREFORE, WE DID NOT REQUEST THEM ANY LONGER. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES. THE TESTING WAS PERFORMED MANUALLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE TESTS WERE PERFORMED AS IMMEDIATE SPIN TEST AND WITH AN INCUBATION FOR 30 MINUTES AT ROOM TEMPERATURE. IN ALL CASES THE POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNDETERMINED. THE COMPLAINT SAMPLE WAS NOT AVAILABLE, AND THE RETENTION SAMPLE REACTED AS EXPECTED. BECAUSE NEITHER THE COMPLAINT SAMPLE NOR THE SPECIMENS THAT CAUSED THE FALSE POSITIVE REACTIONS WERE AVAILABLE, THE ROOT CAUSE OF THE FALSE POSITIVE REACTIONS AT THE CUSTOMER´S SITE REMAINS UNKNOWN. ESPECIALLY SINCE THE CUSTOMER HAD REPORTED THAT IN A REPEAT TEST CONDUCTED WITH A PROLONGED INCUBATION ACCORDING TO THE IFU, THE REACTIONS WERE NEGATIVE. THE POSITIVE REACTION OF THE PATIENT SAMPLE MIGHT BE EXPLAINABLE BY THE PRESENCE OF THE KNOWN COLD AGGLUTININ, BUT NOT THE POSITIVE REACTION OF THE HEMOBIOSCIENCE CONTROL QC1. WE DID NOT RECEIVE ANY OTHER COMPLAINTS REGARDING THIS COMPLAINT REASON. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862803 REAGENT RED BLOOD CELLS BIOTESTCELL A2 BIOTESTCELL A2 QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 9202011-00 07611969952625

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown