BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS BENZODIAZEPINES (BNZG) REAGENT

    MDR report key: 2213762 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-03776
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JXM
    PMA / PMN Number
    K043556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT APPEARS TO BE REAGENT RELATED. SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY POSITIVE BENZODIAZEPINE (BNZG) RESULTS WERE GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FOR A SPECIFIC SYNCHRON SYSTEMS BENZODIAZEPINES (BNZG) REAGENT LOT. INSTRUMENT BNZG QUALITY CONTROLS RESULTS RECOVERED AS POSITIVE FOR NEGATIVE QC CONTROL MATERIALS DURING THE TIMEFRAME OF THIS EVENT. NO ERRONEOUS BNZG RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INITIAL RESULTS WERE REPEATED AT A THIRD PARTY LABORATORY. THE REPEAT RESULTS WERE DIFFERENT FROM THE INITIAL RESULTS, AND WERE CONSIDERED VALID. THE CUSTOMER CHANGED SYNCHRON SYSTEMS BENZODIAZEPINES (BNZG) REAGENT LOTS, AND QUALITY CONTROL RESULTS RESPONDED BY RETURNING BACK INTO ESTABLISHED SPECIFICATION RANGE. DATA PROVIDED BY THE CUSTOMER INDICATES THE GENERATION OF AN INITIAL POSITIVE BNZG RESULT, WHICH UPON REPEAT ON ANOTHER INSTRUMENT GENERATED A NEGATIVE REPEAT RESULT. THE SAMPLES WERE URINE PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® SYSTEMS BENZODIAZEPINES (BNZG) REAGENT ENZYME IMMUNOASSAY, BENZODIAZIPINE JXM BECKMAN COULTER, INC. NA M104042

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM