BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-S

    MDR report key: 745305 · Received July 24, 2006

    Report

    Report Number
    1034569-2006-00066
    Event Type
    Malfunction
    Date Received
    July 24, 2006
    Date of Event
    June 30, 2006
    Report Date
    July 24, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    GMQ
    PMA / PMN Number
    bk950017
    Removal / Correction Number
    FA-06-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION CAPTURE-S INDICATOR CELLS, LOT 229018 WERE TESTED ON AN IN-HOUSE SEMI-AUTOMATED INSTRUMENT WITH RETENTION CAPTURE-S PLATES, LOT S098; CAPTURE-S REACTIVE CONTROL SERUM, LOT 252007; CAPTURE-S NONREACTIVE CONTROL SERUM, LOT 251006 AND IN-HOUSE DONOR SAMPLES. IN-HOUE DONOR SAMPLES WERE NONREACTIVE, AS EXPECTED. CAPTURE-S REACTIVE CONTROL SERUM, LOT 252007 WAS TESTED AS A CONTROL AND AS TEST SAMPLES. CAPTURE-S REACTIVE CONTROL SERUM WAS INTERPRETED AS REACTIVE WHEN USED AS A CONTROL SAMPLE WITH RETENTION LOT OF CAPTURE-S INDICATOR CELLS; IT WAS INTERPRETED AS EQUIVOCAL WHEN READ AS A CONTROL SAMPLE USING THE RETURNED CAPTURE-S INDICATOR CELLS. THE CAPTURE-S REACTIVE CONTROL SERUM WAS INTERPRETED AS EQUIVOCAL IN ALL TESTING WHEN TESTED AS A TEST SAMPLE. INVESTIGATION IS ONGOING. MANUAL CAPTURE-S TESTING WAS PERFORMED. VISUAL SCORING OF CAPTURE-S REACTIVE CONTROL SERUM WAS 4 TO 6, REACTIVE. CAPTURE-S NONREACTIVE CONTROL SERUM WAS NONREACTIVE, AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THEY ARE GETTING UNEXPECTED NEGATIVE REACTIONS FOR SYPHILIS TESTING WITH CAPTURE-S REACTIVE CONTROL SERUM WHEN USING CAPTURE-S INDICATOR CELLS, LOT 229018. THE FIRST TESTING RUN PERFORMED AS EXPECTED, BUT THE 2ND TESTING RUN GAVE NEGATIVE REACTIONS WITH THE REACTIVE CONTROL. THE CUSTOMER ALSO REPORTED THAT THEY WERE GETTING SOME REACTIVE SYPHILIS TEST RESULTS WITH PT SAMPLES; THESE RESULTS WERE CONFIRMED USING RPR TESTING. NO MEDICAL ACTION WAS TAKEN BASED ON THE UNEXPECTED NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-S GMQ GMQ IMMUCOR, INC. * 229018

    Patients

    Seq Age Sex Outcome Treatment
    1 * CAPTURE LISS, LOT #216031.| CAPTURE-S NONREACTIVE CONTROL SERUM, LOT#251006| CAPTURE-S REACTION CONTROL SERUM, LOT 252007| CAPTURE-S MICROTITRATION WELLS, LOT S098