BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265

    MDR report key: 1622868 · Received March 1, 2010

    Report

    Report Number
    1217157-2010-00006
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD.
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT SUBSEQUENTLY WAS TRANSFERRED TO ANOTHER HOSPITAL AND NEW SAMPLE WAS DRAWN AND TESTED WITH A DIFFERENT RAPIDLAB 1265 INSTRUMENT. RESULTS SHOWED 39.3 MMOL/L COMPARED WITH 30.2 MMOL/L ON BECKMAN ANALYZER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A GLUCOSE RESULT OF 27.7 MMOL/L FOR A PT WITH CHRONIC RENAL FAILURE. ANOTHER SAMPLE OBTAINED AT THE SAME TIME WAS RUN ON A BECKMAN ANALYZER WITH A RESULT OF >70 MMOL/L. AN ADD'L SAMPLE FROM THE SAME PT WAS TESTED ON THE INSTRUMENT AND THE RESULT WAS 20.5 MMOL/L. WHEN TESTED ON THE BECKMAN ANALYZER THE RESULT WAS 86.8 MMOL/L. QUALITY CONTROL RUN ON BOTH ANALYZERS WERE WITHIN NORMAL RANGE. THERE WAS NO IMPACT TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1265 RAPIDLAB 1265 CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD. 1265

    Patients

    Seq Age Sex Outcome Treatment
    1