BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-CELL A1 & B

    MDR report key: 8145928 · Received December 10, 2018

    Report

    Report Number
    9610824-2018-00087
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 11, 2018
    Report Date
    October 29, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952243
    PMA / PMN Number
    125208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF SPECIMENS WITH IH-CELL A1&B WHEN TESTED ON IH-1000. THE CUSTOMER STATED THAT THE REACTIONS OF BLOOD GROUP A SAMPLES YIELDED AN UNEXPECTED NEGATIVE REACTION WITH IH-CELL B. HE STATED THAT THE REVERSE TYPE DID NOT MATCH THE FORWARD TYPING. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED, "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. WHEN THE CUSTOMER REPEATED THE REVERSE TYPING IN THE TUBE (USING LISS) IT YIELDED STRONG POSITIVE REACTIONS. SAMPLES WERE SENT TO A REFERENCE LAB AND WERE THERE TYPED CORRECTLY, ALSO IN THE TUBE TEST, WITH NO ENHANCEMENT USED. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE AFFECTED PATIENT DONOR SAMPLES THAT HAD SHOWED A FALSE NEGATIVE REACTION. THEREFORE OUR CONTROL LABORATORY PERFORMED A TITRATION OF THE IH-CELL B OF THE DEFECTIVE LOT 8839011 WITH A KNOWN GROUP A DONOR SAMPLE. THIS TITRATION WAS CARRIED OUT ON THE IH-CARD NEUTRAL AND IN COMPARISON TO TWO DIFFERENT LOTS OF IH-CELL B (LOT 8835011 AND LOT 8843011). THE SERIAL DILUTION WAS PERFORMED FROM 0 TO 32. EACH OF THE THREE LOTS OF IH-CELL B REACTED WITH THE SERA OF THE KNOWN GROUP A SAMPLE TO THE SAME DILUTION FACTOR (1:16). THERE WAS NO REDUCTION IN THE REACTIVITY WITH A ANTIBODIES FROM IH-CELL B LOT 8839011. OUR QUALITY CONTROL LABORATORY ALSO REVIEWED TESTINGS IN WHICH THE SUPPOSEDLY DEFECTIVE PRODUCT WAS USED. NO ABNORMALITIES COULD BE OBSERVED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE DONOR SAMPLES WHICH GAVE NEGATIVE RESULTS MAY HAVE WEAK ISOAGGLUTININS. THE TUBE METHOD CAN GIVE STRONGER REACTIONS THAN GEL FILTRATION FOR REVERSE GROUPING. TESTING BY OUR CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF IH-CELL A1&B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE HAD NEGATIVE INFLUENCES ON 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 FALSE NEGATIVE REACTIONS OF SPECIMENS WITH IH-CELL A1&B ON IH-1000. THE CUSTOMER STATED THAT THE REACTIONS OF BLOOD GROUP A SAMPLES WERE FALSE NEGATIVE WITH IH-CELL B. HE ALSO STATED THAT THE REVERSE TYPE DID NOT MATCH THE FRONT TYPE. 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 SUPPOSEDLY DEFECTIVE PRODUCT FOR "INVESTIGATINAL" TESTING BUT SAID TO RETURN THE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THESE DONOR SAMPLES. 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
    987346 REAGENT RED BLOOD CELLS IH-CELL A1 & B IH-CELL A1 & B; 2X10 ML QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 8839011 07611969952243

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, # (B)(6) | IH-1000, # (B)(6)