BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK 500 ANALYZER

    MDR report key: 3796806 · Received May 7, 2014

    Report

    Report Number
    1217157-2014-00066
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE RED OR BROWN COLOR ON THEIR INSTRUMENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED AFTER REVIEWING TECHNIQUE AND CLEANING INSTRUMENT RESOLVED THIS ISSUE. INSTRUMENT IS FULLY OPERATIONAL. THIS DATA WAS REVIEWED WITH SIEMENS MEDICAL AFFAIRS WITH FOLLOWING CONCLUSION: ABNORMAL COLOR OF URINE REQUIRES FURTHER EVIDENCE OF A PATHOLOGIC STATE. SINCE THE RESULTS ARE NOT AFFECTED THE COLOR DOES NOT INSTIGATE FURTHER INVESTIGATION. BECAUSE THIS ADDITIONAL INFORMATION WAS NOT AVAILABLE FOR THE INITIAL FILED MDR, THE MDR 1217157-2014-00066 WAS FILED. HAD THIS ADDITIONAL INFORMATION BEEN AVAILABLE, THIS EVENT WOULD HAVE BEEN ASSESSED AS NOT REQUIRE FILING MDR AS PER 21 CFR 803.

    Description of Event or Problem · 1

    CUSTOMER REPORTED APPROXIMATELY 30% OF PATIENT RESULTS ARE COMING BACK AS A RED OR BROWN COLOR ON THEIR INSTRUMENT. COLOR IS REPORTED BY THE INSTRUMENT AND ALL SAMPLES ARE NORMAL YELLOW COLOR BY VISUAL INSPECTION. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273785 CLINITEK 500 ANALYZER CT 500 ANALYZER JIO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1