BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2872000 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06323
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 5, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE RAN A CHECK TEST AND ALL RESULTS WERE IN PASSING RANGE. HE STATES THAT THE ANALYZER MODULE LOOKED GOOD AND DID NOT NOTICE ANYTHING OUT OF PLACE OR DIRTY. THE PROBES LOOKED GOOD. THE TECHNICAL SERVICE REPRESENTATIVE RAN A PRECISION AND THIS WAS GOOD. A SPECIFIC CAUSE COULD NOT BE DETERMINED. AS THE CALIBRATION REFERRING TO THE OVER RECOVERED PATIENT RESULTS WAS AFFECTED AS WELL, A HARDWARE RELATED ISSUE IS MOST LIKELY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS VANCOMYCIN RESULTS FOR THREE SAMPLES FROM THE SAME PATIENT. THE FIRST SAMPLE INITIALLY RESULTED AS 43.63 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. SINCE THIS RESULT WAS NOT AS EXPECTED, THE SAMPLE WAS SENT TO A DIFFERENT HOSPITAL WHERE IT WAS REPEATED AND RESULTED AS "3. SOMETHING" UG/ML. THE SAMPLE WAS REPEATED AGAIN ON THE INTEGRA 400 PLUS ANALYZER AFTER CALIBRATION AND QUALITY CONTROLS WERE PERFORMED ON (B)(6) 2012, WHERE IT RESULTED AS 4.26 UG/ML. SAMPLE TWO INITIALLY RESULTED AS >80.00 UG/ML ACCOMPANIED BY A DATA FLAG ON (B)(6) 2012. THIS VALUE WAS EXTRAPOLATED BY THE INSTRUMENT AS 249.57 UG/ML. THE SAMPLE WAS DILUTED X4 AND RESULTED AS 51.84, WHICH WHEN MULTIPLIED BY THE DILUTION FACTOR, WAS 207 UG/ML. THE 207 UG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. SINCE THIS RESULT WAS NOT AS EXPECTED, THE SAMPLE WAS SENT TO A DIFFERENT HOSPITAL WHERE IT WAS REPEATED AND RESULTED AS <1.0 UG/ML. THE SAMPLE WAS REPEATED AGAIN ON THE INTEGRA 400 PLUS ANALYZER AFTER CALIBRATION AND QUALITY CONTROLS WERE PERFORMED ON (B)(6) 2012, WHERE IT RESULTED AS 0.91 UG/ML. SAMPLE THREE INITIALLY RESULTED AS >80.00 UG/ML ACCOMPANIED BY A DATA FLAG ON (B)(6) 2012. THE SAMPLE WAS DILUTED X4 AND RESULTED AS 51.27, WHICH WHEN MULTIPLIED BY THE DILUTION FACTOR, WAS 205 UG/ML. THE 205 UG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. SINCE THIS RESULT WAS NOT AS EXPECTED, THE SAMPLE WAS SENT TO A DIFFERENT HOSPITAL WHERE IT WAS REPEATED AND RESULTED AS <1.0 UG/ML. THE SAMPLE WAS REPEATED AGAIN ON THE INTEGRA 400 PLUS ANALYZER AFTER CALIBRATION AND QUALITY CONTROLS WERE PERFORMED ON (B)(6) 2012, WHERE IT RESULTED AS <0.74 UG/ML ACCOMPANIED BY A DATA FLAG. IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. NO ADVERSE EVENTS WERE ALLEGED. THE VANCOMYCIN REAGENT LOT NUMBER WAS 66487601 WITH AN EXPIRATION DATE OF 09/30/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER LEH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 028 DA CAFFEINE| CEFOTAXIME| VANCOMYCIN