BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2831931 · Received November 14, 2012

    Report

    Report Number
    1823260-2012-05744
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED, THEY RECEIVED QUESTIONABLE INORGANIC PHOSPHORUS (PHOS) RESULTS, ON THEIR P-MODULE. THE CUSTOMER STATED THEY NOTICED THEIR QUALITY CONTROL RESULTS HAD GONE OUT OF RANGE. THE CUSTOMER STATED, THERE MAY HAVE BEEN APPROXIMATELY 125 PATIENT SAMPLES RUN BETWEEN THE TIME THE QUALITY CONTROL WAS INITIALLY RUN AND THE TIME THE QUALITY CONTROL WAS OUT OF RANGE. THE CUSTOMER PROVIDED DATA FOR 13 PATIENTS, OF WHICH THERE WERE 10 PATIENTS WITH DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT TESTING WAS PERFORMED ON AN INTEGRA ANALYZER, ADDITIONAL INFORMATION WAS NOT PROVIDED. THE INITIAL PATIENT SAMPLES WERE PROCESSED BY THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE. THE CUSTOMER STATED NO OTHER ASSAYS WERE AFFECTED. PATIENT 1: INITIAL PHOS RESULT WAS 6.6 MG/DL. THE REPEAT RESULT WAS 3.9 MG/DL. PATIENT 2: INITIAL PHOS RESULT WAS 4.6 MG/DL. THE REPEAT RESULT WAS 2.3 MG/DL. PATIENT 3: INITIAL PHOS RESULT WAS 6.3 MG/DL. THE REPEAT RESULT WAS 3.6 MG/DL. PATIENT 4: INITIAL PHOS RESULT WAS 2.9 MG/DL. THE REPEAT RESULT WAS 2.2 MG/DL. PATIENT 5: INITIAL PHOS RESULT WAS 9.3 MG/DL. THE REPEAT RESULT WAS 6.6 MG/DL. PATIENT 6: INITIAL PHOS RESULT WAS 6.6 MG/DL. THE REPEAT RESULT WAS 3.9 MG/DL. PATIENT 7: INITIAL PHOS RESULT WAS 5.1 MG/DL. THE REPEAT RESULT WAS 3.9 MG/DL. PATIENT 8: INITIAL PHOS RESULT WAS 7.0 MG/DL. THE REPEAT RESULT WAS 4.2 MG/DL. PATIENT 9: INITIAL PHOS RESULT WAS 6.3 MG/DL. THE REPEAT RESULT WAS 3.6 MG/DL. PATIENT 10: INITIAL PHOS RESULT WAS 11.1 MG/DL. THE REPEAT RESULT WAS 4.2 MG/DL. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND ISSUED AS CORRECTED REPORTS. IT WAS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE PHOS R1 REAGENT LOT NUMBER WAS 65055401 AND THE EXPIRATION DATE WAS 01/31/2013. THE PHOS R2 REAGENT LOT NUMBER WAS 65811201 AND THE EXPIRATION DATE WAS 11/30/2013. THE FIELD SERVICE REPRESENTATIVE FOUND A MISADJUSTED R2 PROBE. HE ADJUSTED THE R2 PROBE AND CHECKED ADJUSTMENTS. HE CLEANED THE HIGH AND LOW CONCENTRATION WASTE VALVE WITH BLEACH AND HOT WATER. HE CLEANED THE MASTER VACUUM VALVE WITH HOT WATER. HE CHECKED THE CUVETTE RINSE HEIGHTS. HE PREVENTATIVELY REPLACED THE HEAT CUT FILTER. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WITH PASSING RESULTS.

    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