BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ANTI-D (DVI+)

    MDR report key: 15354461 · Received September 5, 2022

    Report

    Report Number
    9610824-2022-00056
    Event Type
    Malfunction
    Date Received
    September 5, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969962402
    PMA / PMN Number
    125097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WEAK POSITIVE RESULTS WITH THE ANTI-D INSTEAD OF CLEARLY NEGATIVE RESULTS ON IH-1000 WHEN USING THE IH-CARD ANTI-D (DVI+) . ORIGINALLY, THE CUSTOMER STATED THAT HE OBSERVED THIS ISSUE WITH HEMOBIOSCIENCE CONTROL QC3 WHICH IS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER PROVIDED A PRODUCT SAMPLE OF THE AFFECTED IH-CARD ANTI-D (DVI+) FOR INVESTIGATIONAL TESTING . OUR QUALITY CONTROL LABORATORY IS CURRENTLY TESTING THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON IH-1000. THIS TESTING IS ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. ALSO STILL ONGOING IS AN ANALYSIS OF THE TRACE FILES OF THE AFFECTED INSTURMENT IH-1000.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WEAK POSITIVE RESULTS WITH THE ANTI-D INSTEAD OF CLEARLY NEGATIVE RESULTS WHEN TESTING WITH THE E IH-CARD ANTI-D (DVI+) ON THE IH-1000 INSTRUMENT. ORIGINALLY, THE CUSTOMER STATED THAT HE OBSERVED THIS ISSUE ONLY WITH HEMOBIOSCIENCE CONTROL QC3 WHICH IS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER PROVIDED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-CARD ANTI-D (DVI+) FOR INVESTIGATIONAL TESTING AND ALSO THE HEMOBIOSCIENCE QC 3. THE HEMOBIOSCIENCE QC3 WAS ALREADY EXPIRED WHEN WE RECEIVED IT ON OUR PREMISES. OUR QUALITY CONTROL LABORATORY VISUALLY CHECKED THE CARDS RETURNED BY THE CUSTOMER AND THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. ALL ACCEPTANCE CRITERIA WITH REGARD TO INTACT SEALING, CORRECT FILLING HEIGHT, HOMOGENEOUS GEL AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER WERE MET. WE OBSERVED ONLY A SLIGHTLY REDUCED SUPERNATANT IN BOTH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE WHICH HAD NO NEGATIVE IMPACT. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AND THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. IN TOTAL WE TESTED 48 IH-CARDS OF THE SUPPOSEDLY DEFECTIVE LOT. DUE TO THE REASON FOR THE COMPLAINT, THE FOCUS WAS ON THE TESTING OF RHD NEGATIVE SAMPLES ON THE IH-1000. IN SOME CASES THE REACTION WERE ASSESSED AS QUESTION MARK AND NOT AS CLEARLY NEGATIVE. THIS EVALUATION WAS PLAUSIBLE DUE TO SINGLE RED BLOOD CELLS IN THE GEL COLUMN ABOVE THE PELLET. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE DATA FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYZED. WITHIN THE INVESTIGATION OF THE DATA WE OBSERVED THAT THE ISSUE ALSO OCCURRED WITH PATIENT SAMPLES. THE INTERPRETATION "?" OR "+" BY THE INSTRUMENT WAS CONFIRMED AND IS JUSTIFIED DUE TO THE PRESENCE OF FEW AGGLUTINATIONS ABOVE THE PELLET. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). BASED ON THE TEST RESULTS AND THE ANALYSIS OF THE DATA FILES THE COMPLAINT HAD TO BE CONFIRMED. HOWEVER, THE SECTION INTERPRETATION OF RESULTS OF THE INSTRUCTION FOR USE CONTAINED THE FOLLOWING NOTE:" *A VERY WEAK REACTION IS NOT AN EXPECTED RESULT FOR ANTIGEN TESTING. IT MAY INDICATE THAT A FALSE POSITIVE OR A VERY WEAK/PARTIAL EXPRESSION OF THE ANTIGEN IS PRESENT. FURTHER INVESTIGATION OF THIS SAMPLE SHOULD BE PERFORMED BEFORE THE ANTIGEN STATUS IS DETERMINED." THE OBSERVED AND CONFIRMED ISSUE HAS ALREADY BEEN ADDRESSED AND DOCUMENTED IN INTERNAL QUALITY NOTIFICATION (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485038 BLOOD GROUPING REAGENT IH-CARD ANTI-D (DVI+) IH-CARD ANTI-D (DVI+); 48 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 9201080 07611969962402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEMO QC#3, LOT 2206211| HEMO QC#3, LOT 2206211| IH-1000, SN (B)(6)| IH-1000, SN (B)(6)