BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1905488 · Received November 23, 2010

    Report

    Report Number
    1823260-2010-06938
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CREATININE PLUS (CREATININE) RESULTS FOR 29 PATIENT SAMPLES. THEY RECEIVED A PHONE CALL FROM A CLINICIAN QUERYING SEVERAL OF THE CREATININE RESULTS THAT HAD BEEN REPORTED AS THEY DID NOT FIT THE CLINICAL PICTURE OF THE PATIENTS OR THEIR PREVIOUS RESULTS. THE USER REPEATED THE SAMPLES EITHER ON THE SAME INSTRUMENT OR ON ANOTHER INSTRUMENT USING THE SAME REAGENT LOT NUMBER AND RECEIVED DIFFERENT AND MORE BELIEVABLE RESULTS. THEY ASSAYED SOME OF THE SAMPLES A THIRD TIME ON ANOTHER INSTRUMENT AND RECEIVED THE SAME RESULTS AS THE SECOND TESTING. NO DATA WAS PROVIDED FOR THE THIRD TESTING OF THE SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 11 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN UMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 65.1 AND THE REPEAT RESULT WAS 108.1. PATIENT SAMPLE 2 INITIAL RESULT WAS 70.8 AND THE REPEAT RESULT WAS 162.2. PATIENT SAMPLE 3 INITIAL RESULT WAS 139 AND THE REPEAT RESULT WAS 254.2. PATIENT SAMPLE 4 INITIAL RESULT WAS 328.5 AND THE REPEAT RESULT WAS 433.7. PATIENT SAMPLE 5 INITIAL RESULT WAS 248.7 AND THE REPEAT RESULT WAS 444.6. PATIENT SAMPLE 6 INITIAL RESULT WAS 65.1 AND THE REPEAT RESULT WAS 108. PATIENT SAMPLE 7 INITIAL RESULT WAS 28.7 AND THE REPEAT RESULT WAS 80.6. PATIENT SAMPLE 8 INITIAL RESULT WAS 240.9 AND THE REPEAT RESULT WAS 440.1. PATIENT SAMPLE 9 INITIAL RESULT WAS 1089.9 AND THE REPEAT RESULT WAS 1441. PATIENT SAMPLE 10 INITIAL RESULT WAS 386.9 AND THE REPEAT RESULT WAS 577. PATIENT SAMPLE 11 INITIAL RESULT WAS 120.9 AND THE REPEAT RESULT WAS 200.5. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE CREATININE R1 REAGENT LOT NUMBER WAS 628550 AND THE R2 REAGENT LOT NUMBER WAS 628004. THE FIELD SERVICE ENGINEER FOUND A PROBLEM WITH THE MIXER PADDLES. HE REPLACED THEM WHICH RESOLVED ALL THE PRECISION PROBLEMS ON THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1