BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG

    MDR report key: 8110185 · Received November 28, 2018

    Report

    Report Number
    9610824-2018-00081
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 8, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHS
    UDI-DI
    07611969964857
    PMA / PMN Number
    125098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 THAT A SPECIMEN (HEREINAFTER REFERRED TO AS SAMPLE A) WAS TESTED AS A RH (D) POSITIVE ON IH-1000. BUT WHEN THE SPECIMEN WAS RETESTED MANUALLY, THE RESULT WAS B RH (D) POSITIVE. THE CUSTOMER REPEATED THE TESTING ON IH-1000 AND THE RESULT CAME BACK AS B RH (D) POSITIVE. THE CUSTOMER SPECIFIED THAT THERE WERE ONLY TWO SAMPLES ON THE SAME RACK WHICH WERE PROCESSED DIRECTLY ONE AFTER THE OTHER. ONE OF THESE SAMPLES WAS A RH (D) POSITIVE (HEREINAFTER REFERRED AS SAMPLE B). THE INFORMATION INITIALLY PROVIDED BY THE CUSTOMER AND THE COMPLAINED IH-CARD DID NOT FIT TOGETHER. THE CUSTOMER REPORTED AN INCORRECT ABO BLOOD GROUP TYPING, BUT FILED HIS COMPLAINT FOR AN IH-CARD AHG ANTI-IGG (LOT 8825050) WHICH IS NOT SUITED FOR ABO BLOOD GROUP TYPING, BUT FOR ANTIBODY SCREENING AND IDENTIFICATION. THE AFFECTED IH-CARD ABO/D (DVI-)+REV A1,B ART.-NO. 813112100 LOT NO. 8817120 (EXPIRY DATE 2019-08-24) WAS ONLY NOTED WHEN THE TRACE FILE ANALYSIS WAS PERFORMED. THE CUSTOMER DID NOT PROVIDED ANY PATIENT SAMPLE BUT ONLY SOME SCREENSHOTS OF THE RESULTS OF BOTH SAMPLES TESTED. IT WAS NOTED THAT AT THE FIRST TESTING THE IH-1000 WITH THE SERIAL NUMBER 5100022 WAS USED. FIRST SAMPLE LOADED ON THE RACK WAS SAMPLE B WITH THE EXPECTED BLOOD GROUP A RH (D) POSITIVE. THEREAFTER TWO SAMPLES WITH THE SAME BARCODE (REFERRING AS SAMPLE A) WERE LOADED. IN CASE OF THE PRESENCE OF TWO SAMPLES WITH THE SAME BARCODE THE IH-1000 AS A SAFETY SYSTEM AND DISPLAYS THE WARNING MESSAGE "TWO SAMPLE TUBES WITH SAME BARCODE IDENTIFIED" ON THE MAIN-SCREEN AND ONLY THE FIRST SAMPLE TUBE IDENTIFIED WILL BE TESTED. IN THIS CASE, TWO RESULTS WERE OBTAINED FOR THE THREE (3) SAMPLES ON THE SAME RACK. THE RESULTS WERE A RH (D) POSITIVE. THEREFORE, WE HIGHLY SUSPECT THAT THE COMPLAINT WAS MORE LINKED AN USER ERROR BY INCORRECT LABELING OF THE TUBE SAMPLE WHICH COULD EXPLAIN THE DIFFERENCE ON THE BLOOD GROUP RESULTS. FOR FURTHER INVESTIGATIONS, WE REQUESTED THE INFORMATION IF IT IS ACCEPTED AND POSSIBLE AT THE CUSTOMER SITE TO DUPLICATE THE BARCODE SAMPLE. UNFORTUNATELY, THE CUSTOMER HAS NEVER REPLIED TO THIS AND OTHER QUESTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BASED ON THE INFORMATION AVAILABLE WE ASSUME THAT A MIXING OF SAMPLES OCCURRED DUE TO A POSSIBLE DUPLICATION OF THE SAME BARCODE SAMPLE FOR TWO DIFFERENT PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SPECIMEN WAS TESTED AS A RH(D) POSITIVE ON IH-1000 USING THE IH CARD AHG ANTI-IGG. BUT WHEN THE SPECIMEN WAS RE-TESTED MANUALLY, THE RESULT WAS B RH(D) POSITIVE. THE CUSTOMER REPEATED THE TESTING ON IH-1000 AND THE RESULT CAME BACK AS B RH(D) POSITIVE. THE INFORMATION PROVIDED BY THE CUSTOMER AND THE COMPLAINED IH-CARD DO NOT MATCH. THE CUSTOMER REPORTED AN INCORRECT ABO BLOOD GROUP TYPING, BUT FILED HIS COMPLAINT FOR AN IH-CARD AHG ANTI-IGG WHICH IS NOT SUITED FOR ABO BLOOD GROUP TYPING, BUT FOR ANTIBODY SCREENING AND IDENTIFICATION. THEREFORE OUR QUALITY CONTROL LABORATORY REQUIRED THE CORRECT PRODUCT AND LOT INFORMATION, BUT THE CUSTOMER HAS SO FAR NOT COME FORWARD WITH THIS INFORMATION. DUE TO THE LACK OF INFORMATION A TESTING OF THE RETENTION SAMPLE HAS NOT YET BEEN PERFORMED. AND BECAUSE OF THE MISSING LOT INFORMATION A REVIEW OF THE BATCH RECORD DOCUMENTATION OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949460 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG IH-CARD AHG ANTI-IGG 288 CARDS QHS BIO-RAD MEDICAL DIAGNOSTICS GMBH 8825050 07611969964857

    Patients

    Seq Age Sex Outcome Treatment
    1 HI-CARD ABO/D (DVI-)+REV A1,B, LOT 8817120.| IH-1000, #5100013.| IH-1000, #5100013.