BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK 50 ANALYZER

    MDR report key: 2325988 · Received October 28, 2011

    Report

    Report Number
    1217157-2011-00039
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 30, 2011
    Manufacturer
    BAYER CORP.
    Product Code
    JHJ
    PMA / PMN Number
    K960546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER BELIEVES IT IS LIKELY THAT A METABOLITE OF THE METHOTREXATE CAUSED A REACTION WITH THE METHYL RED IN THE MULTISTIX PH REAGENT WHICH RESULTED IN THE PH REAGENT INDICATING THAT THE SAMPLE WAS ACIDIC. THE PH METER WOULD NOT HAVE BEEN EFFECTED AND WOULD HAVE PROVIDED THE CORRECT RESULT. CUSTOMER REPORTED THAT THE REAGENT AND INSTRUMENT WORKED FINE WITH QC MATERIAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DISCREPANT RESULT FOR PH BETWEEN A CLINITEK 50 INSTRUMENT AND A PH PROBE. PATIENT WAS A CHEMOTHERAPY PATIENT TREATED WITH METHOXOTRATE. NO UNNECESSARY MEDICAL PROCEDURE WAS PERFORMED. NO TREATMENT WAS WITHHELD AS A RESULT OF THIS INCIDENT. THERE WAS NO IMPACT TO PATIENT HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK 50 ANALYZER CLINITEK 50 ANALYZER JHJ BAYER CORP. CLINITEK 50

    Patients

    Seq Age Sex Outcome Treatment
    1