BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS SALI SLIDES

    MDR report key: 38954 · Received August 30, 1996

    Report

    Report Number
    1319809-1996-00001
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 6, 1996
    Manufacturer
    JOHNSON &JOHNSON CLINICAL DIAGNOSTICS
    Product Code
    DKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 15 SLIDE CARTRIDGES (270 SLIDES) WERE RETURNED TO CO FOR EVALUATION. THE SLIDES WERE TESTED USING A QUALITY CONTROL FLUID, LOT NUMBER G1272. ALL 270 SLIDES TESTED GAVE RESULTS BETWEEN 12.5 TO 13.2 MG/DL. ALL SLIDES TESTED WERE WITHIN THE EXPECTED QUALITY CONTROL RANGE. PRODUCT PERFORMED WITHIN SPECIFICATIONS. ALLEGED FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    PT SAMPLE MESURED A SALICYLATE OF <1MG/DL (NEGATIVE) USING CO SALICYLATE SLIDES. RESULT REPORTED TO PHYSICIAN. PHYSICIAN REQUESTED A REPEAT OF THE TEST. A FRESH PT SAMPLE WAS DRAWN AND MEASURED USING THE SAME CARTRIDGE OF SLIDES. RESULT WAS 3.0 MG/DL (THERAPEUTIC RANGE). A NEW CARTRIDGE WAS LOADED AND CALIBRATED ON INSTRUMENT. ORIGINAL SAMPLE AND RE-DRAW WERE RUN USING NEW CARTRIDGE. ORIGINAL SAMPLE GAVE 52MG/DL AND RE-DRAW GAVE 47 MG/DL. BOTH RESULTS ARE IN THE TOXIC RANGE FOR SALICYLATE. PHYSICIAN STATED THAT THERE WERE NO ADVERSE EFFECTS DUE TO THE MISREPORTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS SALI SLIDES IN VITRO DIAGNOSTIC DKJ JOHNSON &JOHNSON CLINICAL DIAGNOSTICS NA 2206-0009-4400

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR