BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 5970010 · Received September 22, 2016

    Report

    Report Number
    1823260-2016-01438
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. AS BOTH RESULTS DIFFERED BY THE SAME AMOUNT AND THE REACTION CURVES WERE ACCEPTABLE, A CALIBRATION ISSUE WAS SUSPECTED.THE FIELD SERVICE REPRESENTATIVE FLUSHED THE SYSTEM AND PERFORMED CHECKS WHICH WERE OK. CALIBRATIONS WERE OK AND PRECISION TESTING WAS PERFORMED. THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW CREATININE RESULTS FOR 216 PATIENT SAMPLES FROM (B)(6) 2016. DATA WAS ONLY PROVIDED FOR TWO PATIENT SAMPLES THAT OCCURRED ON (B)(6) 2016. PATIENT 1 INITIAL RESULT WAS 122.9 UMOL/L. THE REPEAT RESULTS WERE 191.3 UMOL/L AND 186.9 UMOL/L. PATIENT 2 INITIAL RESULT WAS 70.1 UMOL/L. THE REPEAT RESULTS WERE 111.2 UMOL/L AND 115.3 UMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY TO A PHYSICIAN. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 160571. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE EXCHANGED THE TURNING TABLE SHEET KIT, CLEANED ALL PIPETTORS, CHECKED THE PRESSURE AND VACUUM, CLEANED THE WATERTANK AND RINSED THE SYSTEM FROM THE WATERTANK. AFTERWARDS, A CELL BLANK WAS OK. THE INVESTIGATION NOTED THE REACTION CURVE LOOKED LIKE WATER DROPLETS HAD FALLEN IN THE CELL DURING THE REACTION. WITH THE PROVIDED INFORMATION AND PRECISION RESULTS, AN ISSUE WITH REAGENT PIPETTING WAS EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621017 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS P MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1