BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL SET GOLD DRB1 SSP UNITRAY KIT

    MDR report key: 3558194 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00057
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Report Date
    May 23, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONFIRMS THE CUSTOMER INCIDENT. THE KIT DATABASE UPDATE FOR 4515010, 017 1103807 INCORRECTLY LABELED LANE 95 AS POSITIVE FOR BOTH THE DRB4 AND DRB5 GENES, REGARDLESS OF BASE PAIR SIZE SELECTED IN LANE. THIS IS A KNOWN DEFECT OF THE UNIMATCH SOFTWARE WHEN USING A FILE WERE THE "^" SYMBOLS ARE PRESENT IN THE DRB4/DRB5 MIX. THE PRESENCE OF THE "^" SYMBOL BREAKS THE SIZE FILTERING FUNCTION OF UNIMATCH WHICH RESULTS IN BOTH DRB4 AND DRB5 DISPLAYED IN THE RESULTS REGARDLESS OF THE PRODUCT SIZE ENTERED BY THE USER. UNIMATCH SOFTWARE RELEASED 04/06/2012 CONTAINED NEW UCH FILES UPDATING THE REACTIVITY OF DRB1 04:33 IN LANE 44 OF THE DRB1 KIT. THE PREVIOUS SOFTWARE VERSION WAS RELEASED WITHOUT THE REQUIRED MANUAL EDITS TO REMOVE THE "^" SYMBOLS IN LANE 95. THE DRB1 UCH FILES HAVE BEEN RECREATED AND THE MANUAL EDITING DONE TO REMOVE THE "^" SYMBOL FROM LANE 95. CORRECTED FIELD RELEASED 05/31/2012. CORRECTION (B)(4) ADDRESSED IN SOFTWARE UPGRADE TO HOSIII. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER DOWNLOADED KIT DATABASE FOR ALL SET GOLD DRB1 SSP UNITRAY KIT (CATALOG # 4515010), LOT #017 1103807 AND NOTED THAT THE LANE 95 BASE PAIR RESULT FILTER WAS NOT FUNCTIONING. RESULTS INCLUDE BOTH A DRB4 AND A DRB5 RESULT WHEN BASE PAIR SELECTION SHOULD HAVE REMOVED ONE TYPE. CUSTOMER COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529230 ALL SET GOLD DRB1 SSP UNITRAY KIT MZI LIFE TECHNOLOGIES CORP. 017 110387

    Patients

    Seq Age Sex Outcome Treatment
    1