BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 11244475 · Received January 28, 2021

    Report

    Report Number
    3002637618-2021-00004
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 8, 2021
    Report Date
    February 18, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JHI
    UDI-DI
    00630414574639
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS INVESTIGATION RESULTS: PERFORMANCE OF THE SUBMITTED CASSETTES, LOT 073058 (EXP 6/30/21) WAS EVALUATED USING A TECH OPS STATUS INSTRUMENT, SN (B)(6). TESTING WAS COMPLETED USING A POOLED NEGATIVE URINE AND A URINE SOLUTION CONTRIVED TO A 25MIU/ML HCG TARGET, WHICH IS THE CONCENTRATION LISTED IN THE CUSTOMER INSERT AS BEING MINIMUM FOR A POSITIVE DETERMINATION. RESULTS: NO FALSE NEGATIVE RESULTS WERE REPORTED. CASSETTES TESTED USING THE NEGATIVE URINE REPORTED AS NEGATIVE WITH NO TEST LINES OBSERVED. CASSETTES TESTED USING THE CONTRIVED POSITIVE URINE REPORTED AS POSITIVE. BASED ON THE DATA COLLECTED, THE CUSTOMER REPORT OF FALSE NEGATIVE HCG PERFORMANCE FROM CLINITEST HCG LOT 073058, AS REPORTED IN GSMS (B)(4), WAS NOT OBSERVED.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS REQUESTED THE CUSTOMER RETURN THE REMAINING REAGENT FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE HCG RESULT ON THE CLINITEK STATUS+ WHEN COMPARED TO A POSITIVE SERUM QUANTITATIVE RESULT ON A NON-SIEMENS LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144067 CLINITEK STATUS+ CLINITEK STATUS+ JHI SIEMENS HEALTHCARE DIAGNOSTICS 10379675 00630414574639

    Patients

    Seq Age Sex Outcome Treatment
    1