BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PF4 ENHANCED ASSAY

    MDR report key: 5391071 · Received January 26, 2016

    Report

    Report Number
    2183608-2016-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    LCO
    PMA / PMN Number
    K053559
    Removal / Correction Number
    2183608-02/15/13-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA(B)(4) WAS INITIATED ON 01-30-2013 TO TRACK ADDITIONAL INVESTIGATION ACROSS PRODUCT LINES, WHICH INCLUDED EVALUATION OF ALL COMPLAINTS FOR LOW POSITIVE CONTROLS, SUBSEQUENT FIELD ACTION/RECALL ACTIVITIES, AND ADDITIONAL INVESTIGATION TO DETERMINE ROOT CAUSE AND IMPLEMENT CORRECTIVE AND PREVENTIVE ACTIONS, BASED ON ROOT CAUSE DETERMINATION. CROSS-FUNCTIONAL ROOT CAUSE ANALYSIS ACTIVITIES PERFORMED AS PART OF THE INVESTIGATION DETERMINED ROOT CAUSE TO BE INSUFFICIENTLY DETAILED OPERATING PROCEDURES. THE MANUFACTURING OPERATORS FAILED TO PROPERLY EVALUATE POTENTIALLY IMPACTED PLATES WHEN THE PF4:PVS COMPLEX RAN OUT AT THE END OF THE MANUFACTURING RUN BECAUSE OF INSUFFICIENTLY DETAILED OYSTER BAY EQUIPMENT AND PLATE MANUFACTURING PROCEDURES. THE ADDITION OF INSUFFICIENT QUANTITY OF PF4:PVS COMPLEX TO THE PLATES LEAD TO VARIATION IN REACTIVITY, WHICH IN TURN COULD LEAD TO POTENTIAL INVALID ASSAY OR FALSE NEGATIVE RESULT. AN INVALID ASSAY WOULD NOT RESULT IN SIGNIFICANT HARM TO PATIENT. A FALSE NEGATIVE RESULT COULD CONTRIBUTE TO A DELAY IN DIAGNOSIS AND INITIATION OF ALTERNATIVE THERAPIES, AND MAY INCREASE THE RISK OF COMPLICATIONS. A VOLUNTARY MEDICAL DEVICE RECALL WAS INITIATED ON 02-04-2013, FOR PF4 ENHANCED ASSAY LOT 3000389. AT THE TIME OF INITIATION OF RECALL, THERE WAS NO PRODUCT REMAINING IN INVENTORY. THE EFFECTIVENESS CHECK OF CUSTOMER CONTACT WAS COMPLETED IN JUNE 2013, WITH 100% OF CONSIGNEES CONFIRMING RECEIPT OF THE RECALL NOTIFICATION AND CONFIRMING DISPOSITION OF AFFECTED PRODUCT. THE RECALL WAS REPORTED TO US FDA AS REQUIRED BY 21 CFR 7.53 (RECALL STATUS REPORTS), AND MEDICAL DEVICE RECALL REPORT NUMBER IS 2183608-02/15/13-001-R. SEVERAL CORRECTIVE ACTIONS WERE IMPLEMENTED TO RESOLVE THE ISSUE AND PREVENT RECURRENCE, AS LISTED BELOW: CREATED ADDITIONAL INSTRUCTIONS FOR TRIAGING ERRORS THAT OCCUR DURING PLATE MANUFACTURE IMPROVED MANUFACTURING DOCUMENTATION BY REQUIRING A WRITTEN DESCRIPTION OF PRODUCTION EVENTS AND OPERATOR ACTIONS PERFORMED DURING A MANUFACTURING RUN. INCREASE QC SAMPLING. IMPLEMENT VOLUME CHECKS TO BETTER DETECT A FAILURE. IMPROVE THE TRAINING PROGRAM FOR EQUIPMENT OPERATORS. MODIFY MANUFACTURING PROCESSES TO ELIMINATE POTENTIAL FAILURE POINTS. RE-EVALUATE PLACEMENT & FUNCTION OF ERROR DETECTORS ON MANUFACTURING EQUIPMENT. EVALUATE THE VALIDATION PERFORMED FOR THE OBPW AND IDENTIFY GAPS NEEDING REMEDIATION.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED ON(B)(6) 2013 ((B)(4)), WHERE CUSTOMER INFORMED ABOUT NOT GETTING CONSISTENT REPLICATE RESULTS WITH PF4 ENHANCED ASSAY LOT 3000389, RUN ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50232 PF4 ENHANCED ASSAY PF4 ENHANCED ASSAY LCO IMMUCOR GTI DIAGNOSTICS, INC. NA 3000389

    Patients

    Seq Age Sex Outcome Treatment
    1