BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTISTIX 10 SG

    MDR report key: 3847704 · Received June 4, 2014

    Report

    Report Number
    1217157-2014-00076
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LJX
    PMA / PMN Number
    K992257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    AN INSPECTION WAS COMPLETED BY TECHNICAL OPERATIONS ON RETURNED REAGENT MULTISTIX 10 SG LOT #401070 & COMPARISON LOT #311023 TESTED BY VISUAL METHOD ON ONE (1) QUALIFIED READER USING TEST SOLUTIONS CONTRIVED TO LEUKOCYTE (LEU) & NITRITE (NIT) SENSITIVITY RANGES PUBLISHED IN REAGENT PRODUCT INSERT [LEU: 5 & 10 C/MCL; NIT: 0.06 & 0.10 MG/DL]. N=12 REPS PER TEST LEVEL, PER LOT. 100% POSITIVE RESULTS FOR BOTH LOTS AT BOTH NIT TEST LEVELS. 100% POSITIVE RESULTS FOR BOTH LOTS AT 10 C/MCL LEU TEST LEVEL. BORDERLINE RESULTS FOR BOTH LOTS AT 5 C/MCL LEU TEST LEVEL -- 5 OF 12 STRIPS FOR THE RETURNED LOT SHOWED TRACE COLOR DEVELOPMENT, AS DID 4 OF 12 STRIPS FOR THE COMPARISON LOT. CUSTOMER OBSERVATION OF FALSE NEGATIVE LEU & NIT RESULTS WHEN VISUALLY READING MULTISTIX 10SG LOT 401070 CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS BEEN REQUESTED TO SEND BACK REAGENT FOR FURTHER INVESTIGATION. THE CAUSE FOR THE DISCORDANT RESULTS IS UNKNOWN. CUSTOMER HAS NOT HAD ANY ADDITIONAL ISSUES SINCE COMPLAINT WAS OPENED.

    Description of Event or Problem · 1

    WHITE BLOOD CELLS/LEUKOCYTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE WHITE BLOOD CELLS (WBC) AND FALSE NEGATIVE NITRITE ON THREE PATIENTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327245 MULTISTIX 10 SG MULTISTIX 10 SG LJX SIEMENS HEALTHCARE DIAGNOSTICS INC 401070

    Patients

    Seq Age Sex Outcome Treatment
    1