BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE

    MDR report key: 6020682 · Received October 12, 2016

    Report

    Report Number
    2250051-2016-00085
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    January 21, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTING ONE EVENT OF RH DISCREPANCY FOR SAMPLE FROM PREGNANT FEMALE. ACCORDING TO CUSTOMER, INITIAL TESTING OF SAMPLE WITH NO HISTORY WAS PERFORMED AT FACILITY USING ORTHO ANTI-D BIOCLONE LOT # DB308A1 EXP 7/16/2017 ON (B)(6) 2016. AT IMMEDIATE SPIN THE RH RESULT WAS NEGATIVE, BUT WITH WEAK D TESTING, POSITIVE REACTIONS WAS NOTED AT THE AHG PHASE (1+). HOWEVER,BECAUSE OF INTERNAL SOP, SITE REPORTED THE BLOOD TYPE OF PATIENT AS RH NEGATIVE TO CLINICIAN. AFTER REPORTING THE RH RESULT AS NEGATIVE, PATIENT WAS ADMINISTERED RHOGAM. NO OTHER DETAILS PROVIDED. ACCORDING TO CUSTOMER, PATIENT IN QUESTION WAS ADMITTED TO HOSPITAL ON (B)(6) 2016 AND WITH TUBE METHOD USING ANTI-D MONOCLONAL ANTISERA REPORTING 3+ AT IMMEDIATE SPIN. (DIFFERENT MANUFACTURE AND LOT # NOT KNOWN)USED BY HOSPITAL. DAILY QC TESTING WAS ACCEPTABLE. CUSTOMER CONFIRMED RESULTS OF RH NEGATIVE WAS REPORTED CLINICIAN, HOWEVER THEY WOULD LIKE TO KNOW WHAT CLONES WERE USED. ORTHO REVIEW IFU WITH CUSTOMER AND CLONES USED IN ANTISERA AND THE PHASES OF REACTIVITY. ISSUE STARTED ON: (B)(6) 2016; REPORTED 9/22/2016. FREQUENCY: 1X. METHODOLOGY USED: TUBE METHOD. INCUBATION TIME (FOR MANUAL TEST ONLY): 15 MINS. REACTION GRADE OBTAINED: 1+ AT AHG PPASE IN TUBE. TEST REPEATED: NO. REAGENT/PROTOCOL-HANDLING (REAGENT): OK. NO PHYSICAL ISSUES NOTED WITH LOT. CUSTOMER STATES THEY PASSED VISUAL INSPECTION. ORTHO DISCUSS IFU WITH CUSTOMER AND LIMITATIONS AND WEAK D TESTING. RECOMMEND CUSTOMER DISCUSS WITH MEDICAL DIRECTOR ON STEPS MOVING FORWARD AND HOW TO HANDLE REACTIONS OBTAINED AT THE AHG PHASE. CUSTOMER SATISFIED WITH DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675812 ORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE ANTI-D BIOCLONE ANTISERA KSZ ORTHO CLINICAL DIAGNOSTICS DB308A1

    Patients

    Seq Age Sex Outcome Treatment
    1