BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

    MDR report key: 11720470 · Received April 23, 2021

    Report

    Report Number
    9610824-2021-00023
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    IN TOTAL, THE CUSTOMER REPORTED THAT SIX DIFFERENT SAMPLES SHOWED FALSE POSITIVE REACTIONS WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON IH-1000. ORIGINALLY, THE CUSTOMER REPORTED THE FALSE POSITIVE RESULT OF ONE PATIENT WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON IH-1000. LATER, THE CUSTOMER REPORTED FIVE MORE FALSE POSITIVE RESULTS WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON IH-1000. THE CUSTOMER RETURNED NEITHER THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT CAUSED FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES AND CONTROLS ON IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES, WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE DAILY JOURNALS OF THE AFFECTED IH-1000 WAS CHECKED. AN INTER-WELL CONTAMINATION WAS CONSIDERED THE LIKELY CAUSE OF THE FALSE POSITIVE RESULTS. THERE ARE TWO POSSIBLE ROOT CAUSES FOR THE INTER-WELL CONTAMINATION: MISADJUSTMENT OF THE NEEDLE OR A BAD STATUS OF THE IH CARD (E.G. PRESENCE OF DROPS IN THE INCUBATION CHAMBER). IN THE INSTRUCTIONS FOR USE, THE FOLLOWING STATEMENTS ARE GIVEN IN THE CHAPTER PRECAUTIONS: DO NOT USE CARDS SHOWING SIGNS OF DRYING, DISCOLORATION, BUBBLES, CRYSTALS OR OTHER ARTIFACTS. DO NOT USE CARDS WITH DAMAGED FOIL STRIPS. DO NOT USE GEL CARDS IF THE GEL MATRIX IS ABSENT OR IF THE LIQUID LEVEL IN THE MICROTUBE IS NOT AT OR BELOW THE GEL MATRIX. A CLEAR LIQUID LAYER SHOULD BE VISIBLE ON TOP OF THE UNIFORM GEL MATRIX IN EACH MICROTUBE. CARDS WITH DISPERSED DROPS OBSERVED AT THE TOP OF THE MICROTUBE, DUE TO IMPROPER STORAGE OR SHIPPING CONDITIONS, HAVE TO BE CENTRIFUGED WITH IH-CENTRIFUGE L OR IH-READER 24 WITH PRESET TIME AND SPEED BEFORE USE. IF DROPS ARE STILL OBSERVED ON TOP OF THE MICROTUBE AFTER ONE CENTRIFUGATION IT IS RECOMMENDED TO NOT USE THE CARD." FURTHERMORE, WE WOULD RECOMMENDED TO REPLACE THE NEEDLE IF IT WAS BENT OR THE COATING WAS DAMAGED, TO CHECK THE CENTERING NEEDLE/WELLS, AND TO PERFORM A WEEKLY MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615912 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8033010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1