BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-CELL A1 & B

    MDR report key: 9346571 · Received November 20, 2019

    Report

    Report Number
    9610824-2019-00069
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 30, 2019
    Report Date
    January 5, 2021
    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
    NC, 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

    THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV A1,B (LOT NO. 8912020) AND IH-CARD ABO/D(DVI-)+REV A1, B (LOT NO. 8920030). THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED SCREEN PRINTS OF SIX (6) SAMPLES THAT CONFIRMED THE FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000 BUT NO FURTHER INFORMATION ABOUT THE PATIENT CLINICAL DETAILS. HOWEVER, THE CUSTOMER PROVIDED THESE 6 SAMPLES TESTED BETWEEN (B)(6 2019 AND (B)(6) 2019 USING THE PREVIOUSLY MENTIONED PRODUCTS. REVIEW OF THE FILES FOR 1 OF THE SAMPLES INDICATED THERE WERE NO INSTRUMENT ERRORS NOTED DURING THE TESTING. CORRECT VOLUMES OF SAMPLE AND IH-CELL A1&B WERE DISPENSED INTO THE WELLS. HOWEVER, FILES WERE NOT AVAILABLE FOR THE REMAINING 5 SAMPLES. THE 6 SAMPLES WERE TESTED WITH IH-CELL A1&B, LOT 8939011, 8943011 AND REVERSE GROUP CELLS FROM ANOTHER MANUFACTURER. THE NEGATIVE RESULTS SEEN AT THE CUSTOMER FACILITY COULD BE REPRODUCED BY OUR PRODUCT SUPPORT. WE ASSUME THAT THE NEGATIVE REVERSE CELL GROUPING RESULTS ARE PATIENT RELATED. IT IS SCIENTIFICALLY PROVEN THAT SOME PATIENTS CAN SHOW A LACK OF ABO ANTIBODIES ESPECIALLY IN OLDER AGE OR WHEN A DIET OF HIGHLY PROCESSED FOODS IS CONSUMED. THE SECTION LIMITATION OF THE INSTRUCTION FOR USE CONTAINS AN APPROPRIATE NOTE: "DECREASED OR MISSING ABO ANTIBODY REACTIVITY MAY BE SEEN IN DISEASE STATES, THE ELDERLY OR INFANTS RESULTING IN FALSE NEGATIVE REACTIONS.". A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AS THE INSTRUCTION FOR USE ALREADY CONTAINS AN APPROPRIATE NOTE, NO FURTHER INVESTIGATIONS OR ACTIONS WERE INITIATED.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV.A1,B AND IH-CARD ABO/D(DVI-)+REV.A1, B FOR HIS TESTIG. HE PROVIDED SCREEN PRINTS OF SIX SAMPLES THAT HAD CAUSED FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER ANNOUNCED TO SEND IN SAMPLES FOR INVESTIGATIONAL TESTING AND WE ARE AWAITING THESE 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
    1146073 REAGENT RED BLOOD CELLS IH-CELL A1 & B IH-CELL A1 & B; 2X10 ML QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 8939011 07611969952243

    Patients

    Seq Age Sex Outcome Treatment
    1 IH CARD ABO RH DVI+, LOT 8912020.| IH CARD ABO RH DVI+, LOT 8912020.| IH CARD ABO RH DVI-, LOT 8920030.| IH CARD ABO RH DVI-, LOT 8920030.| IH-1000, NS 5100056.| IH-1000, NS 5100056.