BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTISTIX 10SG STRIPS

    MDR report key: 3649068 · Received February 14, 2014

    Report

    Report Number
    1217157-2014-00020
    Event Type
    Other
    Date Received
    February 14, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS BEING REQUESTED TO SEND REAGENT BACK FOR FURTHER INVESTIGATION. CUSTOMER INDICATED THAT THEY ARE NOT CURRENTLY USING SIEMENS TEST STRIPS. THE CAUSE FOR THE DISCORDANT RESULTS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1217157-2014-00020 WAS FILED WITH FDA ON FEBRUARY 14, 2014. ADDITIONAL INFORMATION: BASED ON THE ADDITIONAL INFORMATION, SIEMENS TECHNICAL OPERATIONS TESTED CUSTOMER'S RETURNED REAGENT AND COULD NOT CONFIRM COMPLAINT. AS PER THE MODERN URINE CHEMISTRY MANUAL, "A NEGATIVE NITRITE SHOULD NEVER BE INTERPRETED AS INDICATING AN ABSENCE OF BACTERIURIA. THERE ARE SEVERAL REASONS FOR THIS. FIRST-MORNING URINE, OR URINE THAT HAS REMAINED IN THE BLADDER FOR FOUR OR MORE HOURS, IS MOR LIKELY TO YIELD A POSITIVE NITRITE TEST RESULT IN THE PRESENCE OF SIGNIFICANT BACTERIURIA THAN A RANDOM URINE SAMPLE THAT HAVE BEEN IN THE BLADDER ONLY A SHORT TIME. IN THE LATTER TYPE OF SPECIMEN, THERE MAY HAVE BEEN INSUFFICIENT TIME FOR THE CONVERSION OF NITRATE TO NITRITE BY THE INFECTING BACTERIA. SOME STRAINS OF URINARY PATHOGENS DO NOT PRODUCE THE ENZYME NECESSARY TO REDUCE NITRATE TO NITRITE, BUT THES ORGANISMS ARE THE LEAST COMMON PATHOGENS. A NEGATIVE TEST RESULT MAY ALSO OCCUR IF DIETARY NITRATES ARE ABSENT." CUSTOMER HAS BEEN PROVIDED WITH A REPLACEMENT BOTTLE OF REAGENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NEGATIVE NITRITE AND LEUKOCYTES RESULTS ON THE INSTRUMENT WHEREAS CULTURE RESULTS WERE POSITIVE FOR BOTH ANALYTES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97552 MULTISTIX 10SG STRIPS MULTISTIX 10SG JIO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR