BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10790733 · Received November 5, 2020

    Report

    Report Number
    9610824-2020-00079
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 7, 2020
    Report Date
    January 29, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    TTHE CUSTOMER REPORTED HAZY REACTIONS WITH IH-CARD ABO/D(DV-)+REV.A1, B (REF #813 112 100, LOT #8014070) ON IH-1000. THE CUSTOMER STATED THAT THERE WAS A HAZINESS AROUND THE RED CELL PELLET WHICH LED TO A MISINTERPRETATION BY THE INSTRUMENT IN THREE CASES. THE CUSTOMER RETURNED ONE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT LOT. DUE TO THE BAD CONDITION OF THE PATIENT SAMPLE IT COULD NOT BE TESTED ON IH-1000, BECAUSE THE INSTRUMENT STOPPED PROCESSING. THEREFORE THE PATIENT SAMPLE WAS TESTED MANUALLY WITH OUR QUALITY CONTROL LABORATORY'S RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT, BUT THE READING WAS DONE USING IH-READER 24. THE PATIENT SAMPLE YIELDED CLEAR RESULTS WITHOUT HAZINESS: BLOOD GROUP O RH(D) POSITIVE. ADDITIONALLY THE RETENTION SAMPLE WAS TESTED WITH DIFFERENT DONOR SAMPLES ON IH-1000. THE TESTING WAS PERFORMED WITH THE RETENTION SAMPLE OF IH-LISS RACK (LOT # 760000000013,THE SAME LOT THE CUSTOMER HAD USED) AND IH-CELL A1&B LOT #8039021. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT AND CLEAR. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION CAUSED BY HAZINESS. THE PATIENT SAMPLE DID NOT SHOW ANY HAZINESS AND THE RETENTION SAMPLE REACTED AS EXPECTED. THE ROOT CAUSE OF THE HAZINESS AT CUSTOMER´S SITE REMAINED UNKNOWN. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAZY REACTIONS ON THE IH-CARD ABO/D(DVI-)+REV.A1, B ON IH-1000. THE CUSTOMER STATED THAT DUE TO THE HAZINESS AROUND THE PELLET NEGATIVE REACTIONS WERE ASSESSED AS WEAK POSITIVE ALTHOUGH THEY WERE SUPPOSED TO BE NEGATIVE. THE CUSTOMER PROVIDED IMAGES OF THE IH-1000 WHICH SHOWED THE DESCRIBED ISSUE. IN TWO CASES A HAZY REACTION WITH THE ANTI-B WAS ASSESSED AS 1+ POSITIVE, ALTHOUGH THEY WERE NEGATIVE. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT ONE PATIENT SAMPLE (#: (B)(6)). THE INVESTIGATION OF THE PATIENT SAMPLE IS STILL ONGOING. IN THE MEANTIME OUR QUALITY CONTROL (QC) LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL NEGATIVE REACTIONS WERE CLEAR. WE DID NOT OBSERVE ANY HAZY REACTIONS. THE INVESTIGATION OF THE PATIENT SAMPLE AS WELL AS A REVIEW OF THE BATCH RECORD DOCUMENTATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260171 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1, IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8014070 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, #5100073.| IH-1000, #5100073.| IH-LISS RACK, LOT # 760000000013.