BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8762148 · Received July 4, 2019

    Report

    Report Number
    9610824-2019-00029
    Event Type
    Malfunction
    Date Received
    July 4, 2019
    Date of Event
    May 29, 2019
    Report Date
    October 7, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969964529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT. IT COULD CLEARLY BE DEMONSTRATED THAT THE PATIENT SAMPLE WAS A D TYPE THAT HAD TO REACT POSITIVELY WITH THE ANTI-D OF THE IH-CARD ABO/D (DVI-)+REV.A1, B.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RH D DISCREPANT RESULTS OF ONE FEMALE PATIENT. THE FEMALE PATIENT WAS FIRST TYPED AT AN OUTSIDE LAB AS BLOOD GROUP AB RHD NEGATIVE. ON (B)(6) 2019 A NEW SAMPLE OF THE PATIENT WAS DRAWN AND TESTED WITH IH-CARD ABO/D (DVI-) +REV.A1, B ON IH-1000. THE FEMALE PATIENT WAS TYPED AS BLOOD GROUP AB RHD POSITIVE. THE CUSTOMER DID RETURN THE PATIENT SAMPLE THAT HAD CAUSED THE DISCREPANT RESULT FOR INVESTIGATIONAL TESTING BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. DUE TO THE SMALL AMOUNT OF THE PATIENT SAMPLE THE TESTING WAS DONE MANUALLY. THE PATIENT SAMPLE YIELDED A 3+ POSITIVE RESULT WITH THE ANTI-D. FURTHERMORE THE PATIENT SAMPLE WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR TYPING OF THE RHD. BASED ON THE INTERNAL EVALUATION OF THE EXTERNAL RAW DATA, IT COULD CLEARLY BE DEMONSTRATED THAT THE PATIENT SAMPLE WAS A D TYPE THAT HAD TO REACT POSITIVELY WITH THE ANTI-D OF THE IH-CARD ABO/D(DVI-) +REV.A1, B. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF IH-CARD ABO/D (DVI-)+REV.A1, B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RH D DISCREPANT RESULTS OF ONE FEMALE PATIENT WITH IH-CARD ABO/D(DVI-) +REV.A1, B ON IH-1000.THIS FEMALE PATIENT WAS FIRST TYPED AS BLOOD GROUP AB RHD NEGATIVE AT AN OUTSIDE LABORATORY ON APRIL 1ST 2019. ON MAY 29, 2019 A NEW SAMPLE OF THE PATIENT WAS DRAWN AND TESTED WITH IH-CARD ABO/D(DVI-) +REV.A1,B LOT # 8845100, B ON IH-1000. THE CUSTOMER STATED THAT THE FEMALE PATIENT WAS TYPED AS BLOOD GROUP AB RHD POSITIVE. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE THAT HAD CAUSED THE DISCREPANT TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. DUE TO THE SMALL AMOUNT OF THE PATIENT SAMPLE THE TESTING WAS DONE MANUALLY. THE PATIENT SAMPLE YIELDED A 3+ POSITIVE RESULT WITH THE ANTI-D. THE PATIENT SAMPLE WAS ALSO SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR TYPING OF THE RHD. THE OUTCOME OF THE EXTERNAL TESTING IS: RHD * DVI.1 (A273A). IT CONFIRMS THE EXISTENCE OF A D VARIANT. NEVERTHELESS THE PATIENT SAMPLE YIELDED A CORRECTLY POSITIVE RESULT WITH THE ANTI-D OF THE IH-CARD. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF IH-CARD ABO/D(DVI-)+REV.A1, B. 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 RH D DISCREPANT RESULTS OF ONE FEMALE PATIENT WITH IH-CARD ABO/D(DVI-) +REV.A1, B ON IH-1000. THIS PATIENT WAS TYPED AS BLOOD GROUP AB RHD NEGATIVE AT AN OUTSIDE LABORATORY ON APRIL 1ST 2019. ON (B)(6) 2019 A NEW SAMPLE OF THE PATIENT WAS DRAWN AND TESTED WITH IH-CARD ABO/D(DVI-) +REV.A1,B LOT # 8845100, B ON IH-1000 (SERIAL NUMBER # (B)(4)). THE CUSTOMER STATED THAT THE FEMALE PATIENT WAS TYPED AS BLOOD GROUP AB RHD POSITIVE. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE THAT HAD CAUSED DISCREPANT RESULTS. TESTING IN OUR QUALITY CONTROL LABORATORY AND AN EXTERNAL LABORATORY IS STILL ONGOING. 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
    556665 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1 IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8845100 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, # 5100078| IH-1000, # 5100078| IH-1000, # 5100078