BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTISTIX 8 SG REAGENT STRIPS FOR URINALYSIS

    MDR report key: 6921887 · Received October 6, 2017

    Report

    Report Number
    3002637618-2017-00135
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    August 25, 2017
    Report Date
    February 27, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIR
    PMA / PMN Number
    K992257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS TESTED THE SUBMITTED REAGENT STRIPS WHICH SHOWED NO OBVIOUS VISIBLE DAMAGE OR DEGRADATION. THE BOTTLE ARRIVED TIGHTLY CAPPED AND CONTAINING THE EXPECTED DESICCANT. NO PATIENT SAMPLES WERE SUBMITTED. ALL VALUES FOR BOTH TEST SOLUTIONS REPORTED IN THE EXPECTED RANGES: STRIPS TESTED WITH POSITIVE (42 CELL/MCL) LEUKOCYTE SOLUTION DEVELOPED THE CHARACTERISTIC PURPLE COLOR ON THE LEUK PAD, MATCHING THE 30-47 NUMERIC DESIGNATION RANGE FOR SMALL POSITIVE. STRIPS TESTED WITH POSITIVE (0.15 MG/DL) NITRITE SOLUTION DEVELOPED DEFINITE POSITIVE COLOR ON THE NIT PAD, AVERAGING WELL INTO THE 15-30 NUMERIC DESIGNATION RANGE FOR POSITIVE RANGE. CONCLUSION: THE CUSTOMER REPORT OF FALSE LEUKOCYTE AND BACTERIA RESULTS WHEN VISUAL TESTING WITH MULTISTIX 8SG WAS NOT OBSERVED.

    Additional Manufacturer Narrative · 1

    THE REAGENT HAS BEEN REQUESTED TO BE RETURNED FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT NO REAGENT WILL BE RETURNED. THE CAUSE OF THE DISCREPANCY IN RESULTS CANNOT BE DETERMINED BASED UPON THE INFORMATION THAT THE CUSTOMER PROVIDED. PROPER TECHNIQUE AND MAINTENANCE WERE REVIEWED WITH THE CUSTOMER. THE CUSTOMER STATED THAT THEY ARE NO LONGER USING MULTISTIX 8 SG STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE LEUKOCYTE AND BACTERIA ON THE MULTISTIX 8 SG REAGENT STRIPS FOR URINALYSIS, READ VISUALLY, WHEN COMPARED TO THE MICROSCOPIC EXAM OF THE SEDIMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702461 MULTISTIX 8 SG REAGENT STRIPS FOR URINALYSIS MULTISTIX 8 SG JIR SIEMENS HEALTHCARE DIAGNOSTICS 702038

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR