BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1998066 · Received February 22, 2011

    Report

    Report Number
    1823260-2011-00978
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER INTERMITTENTLY RECEIVED QUESTIONABLE CREATININE PLUS/ENZYMATIC (CREATININE) RESULTS AND PROVIDED DATA FOR TWO PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYTICAL P MODULE (SERIAL NUMBER WAS NOT PROVIDED). ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 1.7. THE REPEAT RESULT WAS 1.7, AND ON (B)(6) 2011 WERE 0.9 AND 0.9. THE SAME SAMPLE FROM THE PATIENT HAD BEEN TESTED ON A POINT OF CARE (POC) DEVICE WHILE IN THE ER PRIOR TO THE TESTING OF THE SAMPLE IN THE LABORATORY. THE RESULT FROM THE POC DEVICE WAS 0.6. PATIENT SAMPLE 2 INITIAL RESULT WAS 1.7. THE REPEAT RESULT WAS 1.9, AND ON THE NEXT DAY WERE 0.9 AND 0.9. THE INITIAL RESULT WAS FLAGGED WITH A DELTA CHECK IN THE HOST SYSTEM TRIGGERING THE REPEAT TESTING. THE DATE OF TESTING FOR PATIENT SAMPLE 2 WAS UNKNOWN. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NEITHER PATIENT WAS TREATED OR AFFECTED DUE TO THE ERRONEOUS RESULT. THE CREATININE REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A LOOSE NUT CONNECTION TO THE REAGENT SYRINGE. HE PERFORMED PREVENTIVE MAINTENANCE AND TIGHTENED THE CONNECTIONS TO THE SYRINGES. TO VERIFY THE ANALYZER OPERATION, HE TESTED THE SYSTEM IN DIAGNOSTIC MODE. THE USER RAN QUALITY CONTROL WITH ACCEPTABLE RESULTS AND RAN PRECISION TESTING WITH RESULTS WITHIN SPECIFICATIONS. THE FIELD APPLICATION SPECIALIST ADJUSTED THE REAGENT PROBES AND REPLACED THE REAGENT STIRRER AS IT WAS BENT. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING THEN RELOADED THE ORIGINAL REAGENT PACK AND RAN PRECISION TESTING. BOTH PRECISIONS WERE ACCEPTABLE.

    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