BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHIUM

    MDR report key: 2088566 · Received May 13, 2011

    Report

    Report Number
    1823260-2011-02602
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    PMA / PMN Number
    K063684
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6). PRECISION CHECKS WERE PERFORMED WITH THE %CV WITHIN SPECIFICATIONS. THE GEAR PUMP PRESSURE WAS CHECKED AND FOUND TO BE ON THE LOW SIDE. IT WAS ADJUSTED TO WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NO EVIDENCE OF SAMPLE OR REAGENT CARRYOVER. NO APPLICATION OR REAGENT RELATED ISSUE COULD BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6). OTHER: NA.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN ONGOING ISSUE WITH QUESTIONABLE LITHIUM RESULTS FROM THE COBAS 6000 C501 MODULE, (B)(4), SINCE (B)(6) 2011. DATA WAS PROVIDED FOR THREE PATIENT SAMPLES, OF WHICH THE RESULTS FOR TWO WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL LITHIUM RESULT WAS 1.70 MMOL/L. THE SAMPLE WAS REPEATED THREE TIMES WITH RESULTS OF 0.68, 0.66, AND 0.64 MMOL/L. ALL RESULTS WERE ACCOMPANIED BY DATA FLAGS. ON (B)(6) 2011, PATIENT SAMPLE 2 INITIAL LITHIUM RESULT WAS 1.70 MMOL/L. THE SAMPLE WAS REPEATED THREE TIMES WITH RESULTS OF 0.75, 0.76, AND 0.76 MMOL/L. ALL RESULTS WERE ACCOMPANIED BY DATA FLAGS. IT IS UNKNOWN WHICH RESULTS, IF ANY, WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHIUM ASSAY, PORPHYRIN, SPECTROPHOTOMETRY, LITHIUM NDW ROCHE DIAGNOSTICS NA 61733301

    Patients

    Seq Age Sex Outcome Treatment
    1