BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11601431 · Received April 1, 2021

    Report

    Report Number
    9610824-2021-00019
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 1, 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
    NJ, 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 1+ POSITIVE AND QUESTION MARK RESULTS WITH IH-CARD ABO/D(DVI-)+REV.A1, B WHEN USED ON IH-1000. THE CUSTOMER STATED THAT THE REACTIONS WERE VISUALLY ASSESSED CLEARLY NEGATIVE AND SHE SUSPECTED THAT THE INCORRECT RESULTS WERE CAUSED BY SCRATCHES. THE CUSTOMER DESCRIBED THE ISSUE AS "ONGOING" BUT DID NOT PROVIDE ANY OTHER DATE OF EVENT BESIDES (B)(6) 2021. SO WE REFRAINED FROM SENDING SEVERAL IDENTICAL REPORTS FOR THESE UNKNOWN DATES. THE CUSTOMER RETURNED IH-CARDS OF THE SUPPOSEDLY DEFECTIVE LOT AND PROVIDED RESULT IMAGES. OUR QUALITY CONTROL LABORATORY CHECKED THEM VISUALLY AND TESTED THEM IN PARALLEL WITH IH-CARDS OF THEIR RETENTION SAMPLE. WE OBSERVED DUST ON THE CARDS AND SOME NOTICEABLE LINES BETWEEN THE WELLS WHICH MIGHT BE CALLED SCRATCHES BY THE CUSTOMER, BUT WE DID NOT OBSERVE ANY REAL SCRATCHES ON THE CARDS. THE OBSERVED LINES WERE BARELY VISIBLE TO THE NAKED EYE. OUR QUALITY CONTROL LABORATORY PROCESSED CARDS WITH THE OBSERVED LINES IN THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NEITHER OBSERVE ANY QUESTION MARK NOR FALSE POSITIVE RESULTS. THE DUST WHICH CAUSED MISINTERPRETATION WAS ONLY OBSERVED ON THE IMAGES AND ON THE CARDS THE CUSTOMER HAD SENT IN FOR INVESTIGATIONAL TESTING, NOT ON THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THEREFORE, WE HIGHLY RECOMMEND TO THE CUSTOMER TO CHECK THE STORAGE CONDITIONS OF THE CARDS AT HER SITE. WE WOULD LIKE TO REFER TO THE CHAPTER STORAGE REQUIREMENTS OF THE INSTRUCTION FOR USE: "DO NOT STORE NEAR ANY HEAT, AIR CONDITIONING SOURCES OR VENTILATION OUTLETS." THE MARKED STREAKS ARE FLOW MARKS FROM MOLD INJECTION AND NOT ANY SCRATCHES. THEY CAN BE OBSERVED IN EVERY BATCH AND ARE UNSIGHTLY BUT NOT CRITICAL, SINCE THEY ARE OUTSIDE THE AREA OF THE IMAGE ANALYSIS. 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
    497927 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 8042010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1