BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1635892 · Received March 22, 2010

    Report

    Report Number
    1823260-2010-01724
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 28, 2010
    Report Date
    March 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED NEGATIVE RESULTS WHEN SHE RAN HER QC, IT WAS ALL OUT OF RANGE. SHE RERAN QC WHICH SHE WAS ABLE TO RECOVER WITHIN RANGE AND RERAN PATIENT SAMPLES. ISSUE INVOLVED MULTIPLE ASSAYS. SHE PROVIDED RESULTS FOR FIVE PATIENTS, TWO WERE DISCREPANT, ALL REPEAT TESTING PERFORMED ON ANOTHER MODULE OF THE ANALYZER. PATIENT 1, INITIAL LIPASE RESULT 194 (ACCOMPANIED BY H DATA FLAG), REPEAT GAVE 37 U/L. PATIENT 2, INITIAL ALT RESULT 9, REPEAT GAVE 49 U/L (ACCOMPANIED BY H FLAG); INITIAL CALCIUM RESULT 12.0 (ACCOMPANIED BY H DATA FLAG), REPEAT 10.5 MG/DL; INITIAL TOTAL BILIRUBIN 1.4 (ACCOMPANIED BY H DATA FLAG). REPEAT 0.4 MG/DL. INITIAL RESULTS WERE NOT REPORTED, NO PATIENT TREATMENT WAS PERFORMED BASED ON ERRONEOUS RESULTS. REAGENT LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED CAUSE OF THE DISCREPANCIES WAS MISALIGNMENT OF THE R2 REAGENT PROBE . CUSTOMER ADJUSTED THE PROBE. FIELD SERVICE REPRESENTATIVE FOLLOWED UP WITH INSPECTION OF THE INSTRUMENT WHICH WAS WITHIN SPECIFICATION. HE CHECKED AND VERIFIED PERFORMANCE OF THE R2 REAGENT PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINCIAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1