BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONORSCREEN-HLA CLASS I AND CLASS II

    MDR report key: 5912783 · Received August 29, 2016

    Report

    Report Number
    2183608-2016-00004
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Date of Event
    June 28, 2016
    Report Date
    August 1, 2016
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK070045
    Removal / Correction Number
    INTERNAL # FA-17-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ((B)(4)) RECEIVED FOR FAILED RUN WITH DONORSCREEN-HLA CLASS I AND CLASS II ASSAY (DSI+II) LOT 3002728A FOR ASSAY RUN ON (B)(6) 2016. TECHNICAL SUPPORT REVIEWED CUSTOMER'S DATA FROM THE FAILED ASSAY AND DETERMINED THAT NEGATIVE SERUM CONTROL-CLASS I VALUE (0.176) DID NOT MEET QUALITY CONTROL CRITERIA. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), DONORSCREEN-HLA CLASS I ASSAY CONTROL REQUIREMENTS ARE MEAN OF PC >= 1.500 AND MEAN OF NC >= 0.040 AND <= 0.150. CUSTOMER CONFIRMED THAT STAFF RUNS FULL PLATES. FAILED ASSAY WOULD RESULT IN CUSTOMER HAVING TO REPEAT TESTING, SO THERE IS NO HARM TO PATIENT BUT RATHER A DELAY IN RESULTS. THIS FAILURE MODE, WHERE INCREASED NEGATIVE SERUM CONTROL-CLASS I VALUE RESULTED IN INVALID ASSAY, WAS IDENTIFIED DURING INVESTIGATION FOR A PRIOR COMPLAINT ((B)(4)) FOR DONORSCREEN-HLA LOT 3002728A. INVESTIGATION FOR (B)(4) CONFIRMED THAT ONLY FULL PLATES WITH LOT 3002728A EXHIBITED THIS FAILURE. A FIELD ACTION (MARKET WITHDRAWAL; IMMUCOR GTI DIAGNOSTICS INC. INTERNAL #(B)(4)) WAS INITIATED ON 07-28-2016, FOR DONORSCREEN-HLA ASSAY LOT 3002728A AND THE ADDITIONAL REAGENTS PACKAGING LOT 3002728B, DUE TO PRODUCT MALFUNCTION. US FDA WAS NOTIFIED OF THE FIELD ACTION ON 07-28-2016. EMAIL RESPONSE WAS RECEIVED FROM FDA ON 08-02-2016 EVALUATING THE FIELD ACTION AS MARKET WITHDRAWAL, WITH NO ADDITIONAL REPORTING REQUIRED. AN MDR (MFR REPORT # 2183608-2016-00003) WAS SUBMITTED TO US FDA ON 08-04-2016, FOR COMPLAINT (B)(4). (B)(4) HAS BEEN INITIATED TO CORRECT AND PREVENT RECURRENCE OF THIS ISSUE. CUSTOMER WAS ASKED TO DISCARD REMAINING KITS OF DONORSCREEN-HLA LOT 3002728A/B. CUSTOMER REPORTED THAT THEY DISCONTINUED USING THE LOT AND DID NOT REPORT RESULTS DUE TO ASSAY FAILURE. CUSTOMER WAS SENT 2 REPLACEMENT KITS, AS REQUESTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561781 DONORSCREEN-HLA CLASS I AND CLASS II DONORSCREEN-HLA CLASS I AND CLASS II ASSAY MZI IMMUCOR GTI DIAGNOSTICS, INC. NA 3002728A

    Patients

    Seq Age Sex Outcome Treatment
    1