BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 10769892 · Received November 2, 2020

    Report

    Report Number
    9610824-2020-00076
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952380
    PMA / PMN Number
    125207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY USED BIOTESTCELL 1&2 (REF #816014100, LOT #8035011-00) IN THE TUBE TEST AND DID NOT PICKUP AN ANTI-D. THE CUSTOMER STATED THAT THEY USED THE TUBE TEST FOR BOTH QC AND PATIENT SAMPLES WITH A PASSIVE ANTI-D. HE ALSO STATED THAT THE ANTI-D WAS PICKED UP WHEN THE REAGENT WAS USED ON THEIR IH-500. THE CUSTOMER USED IH BASIC QC AS CONTROL (QC). THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT CAUSED THE FALSE NEGATIVE TEST RESULT AND HE ALSO PROVIDED A TABLE WITH THEIR TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG LOT 8846130-05 USED BY THE CUSTOMER FOR POTENCY. THE TESTING WAS DONE IN PARALLEL TO A REFERENCE LOT (LOT #8948030-05). BOTH LOTS MET THE ACCEPTANCE CRITERION. THE RETENTION SAMPLE OF BIOTESTCELL 1&2 WAS TESTED FOR SPECIFICITY IN THE TUBE METHOD (30 MINUTES INDIRECT ANTIGLOBULIN TEST (IAT). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ADDITIONALLY THE D ANTIGENICITY OF THE RETENTION SAMPLE OF BIOTESTCELL 1&2 LOT #8035011-00 WAS TESTED. AGAIN, THE ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY WEAKENED D ANTIGENICITY OF THE REAGENT RED BLOOD CELLS. WE WOULD LIKE TO POINT OUT, THAT THE INTENDED USE OF IH-BASIC QC IS THE IH-SYSTEM AND NOT THE TUBE TEST. IN THE INSTRUCTION FOR USE OF THE IH-BASIC QC THE CONCENTRATION OF THE ANTI-D WAS GIVEN: 0.05 IU/ML. ACCORDING TO OUR EXPERIENCE THE TUBE TEST IS NOT SENSITIVE ENOUGH TO DETECT THIS LOW CONCENTRATION, IN CONTRAST TO THE IH GEL METHOD. THE FALSE NEGATIVE REACTIONS OF THE PASSIVE ANTI-D SAMPLES REMAINED UNKNOWN, BECAUSE THE SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. BUT WE WOULD LIKE TO NOTE THAT THE CHAPTER LIMITATIONS CONTAINS THE FOLLOWING PART: "NEGATIVE REACTIONS WILL BE OBTAINED IF THE SAMPLE CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED. NO TEST METHOD IS CAPABLE OF DETECTING ALL RED CELL ANTIBODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237041 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 8035011-00 07611969952380

    Patients

    Seq Age Sex Outcome Treatment
    1