BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2871785 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06321
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 THAT THEY HAD BEEN RECEIVING QUESTIONABLE CREATININE PLUS VER.2 (CREA) RESULTS SINCE YESTERDAY IN THEIR C501 ANALYZER. THE CUSTOMER STATED THAT QUALITY CONTROL AND PATIENT RESULTS HAD BEEN TRENDING LOW SINCE YESTERDAY EVENING FOR CREA, URIC ACID, AND CHOLESTEROL. THE CUSTOMER PROVIDED DATA FOR 33 PATIENTS, OF WHICH 18 PATIENTS HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT TESTING WAS PERFORMED ON ANOTHER C501 ANALYZER, SERIAL NUMBER (B)(4). PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.6 MG/DL. THE REPEAT RESULT WAS 1.1 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.6 MG/DL. THE REPEAT RESULT WAS 1.5 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.6 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 1.6 MG/DL. THE REPEAT RESULT WAS 3.1 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.7 MG/DL. THE REPEAT RESULT WAS 1.4MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.7 MG/DL. THE REPEAT RESULT WAS 1.4 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.6 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.5 MG/DL. THE REPEAT RESULT WAS 0.9 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 2.1 MG/DL. THE REPEAT RESULT WAS 3.0 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 1.7 MG/DL. THE REPEAT RESULT WAS 2.7 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.7 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.8 MG/DL. THE REPEAT RESULT WAS 1.4 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 1.0 MG/DL. THE REPEAT RESULT WAS 1.7 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.7 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.5 MG/DL. THE REPEAT RESULT WAS 0.9 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.4 MG/DL. THE REPEAT RESULT WAS 0.9 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.6 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT (B)(6) HAD AN INITIAL CREA RESULT OF 0.6 MG/DL. THE REPEAT RESULT WAS 1.1 MG/DL. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND ISSUED AS CORRECTED REPORTS. THERE WERE NO ADVERSE EVENTS. THE CREA REAGENT LOT NUMBER WAS 66900201 AND THE EXPIRATION DATE WAS 06/30/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE THE CAUSE OF THIS EVENT. HE NOTED THERE WAS WATER ON THE SURFACE OF THE CELLS AND ON THE UNDERSIDE OF THE METAL GUARDS OF THE ULTRA-SONIC MIXERS AND REAGENT PROBE AREAS. THE RINSE WATER VOLUME IN THE CELLS MAY HAVE BEEN MISADJUSTED. HE PERFORMED CHECKS ON THE RINSE MECHANISM NOZZLES, VACUUM, AND WATER/DETERGENT DISPENSE VOLUMES. HE CHECKED THE TUBING FOR THE RINSE WATER AND VACUUM MECHANISM. HE ADJUSTED THE AMOUNT OF WATER BEING DISPENSED SLIGHTLY LOWER. HE REPLACED THE FRONT HEAD VACUUM PUMP DIAPHRAGM DUE TO A SMALL CRACK ON THE UNDERSIDE OF THE DIAPHRAGM, BUT NOT FOR IT LEAKING PRESSURE. HE CHECKED THE GEAR PUMP PRESSURE AND THE INTERNAL PROBE RINSE WATER VOLUMES. HE PERFORMED A PROBE CHECK ON ALL PROBES. HE PERFORMED MECHANISM CHECKS WITH NO WATER FOUND ON THE REACTION CELL SURFACES. HE PERFORMED QUALITY CONTROL WITH RESULTS WITHIN THE CUSTOMER'S RANGES. HE CALIBRATED WITH PASSING RESULTS. HE RAN A PRECISION TEST WITH PASSING RESULTS. HE RAN QUALITY CONTROL AGAIN WITH RESULTS AGAIN WITHIN THE CUSTOMER'S RANGES. HE VERIFIED WITH THE LABORATORY MANAGER THAT THERE HAD NOT BEEN ANY FALSE LOW RESULTS SINCE HIS VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1