BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 9687788 · Received February 10, 2020

    Report

    Report Number
    3002637618-2020-00002
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 27, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JHI
    UDI-DI
    00630414574639
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SINGLE SEALED BOX (25 CASSETTES) OF CLINITEST HCG REAGENT LOT 071962 (EXP 2021-03-31) WAS SENT TO TECHNICAL OPERATIONS FOR INVESTIGATION. NO PATIENT SAMPLE NOR INSTRUMENT WERE SENT. THE SUBMITTED REAGENT SHOWED NO OBVIOUS SIGNS OF DAMAGE OR DEGRADATION; CARTON DISPLAYED INTACT TAMPER-EVIDENT SEAL, INDIVIDUAL CASSETTE FOIL PACKAGES PROPERLY SEALED, CONTAINING THE EXPECTED DESICCANT & MICROPIPETTE. PERFORMANCE OF THE SUBMITTED CASSETTES WAS EVALUATED ON A BANK OF TWO (2) AUDITED CLINITEK STATUS+ INSTRUMENTS (S/N (B)(6)). TESTING WAS COMPLETED USING A URINE SOLUTION CONTRIVED TO A 25 MIU/ML HCG TARGET, WHICH IS THE CONCENTRATION LISTED IN THE CUSTOMER INSERT AS BEING MINIMUM FOR A POSITIVE DETERMINATION. TWELVE (12) REPLICATE TEST VALUES WERE COLLECTED. NO FALSE NEGATIVE RESULTS WERE OBSERVED. BASED ON THE DATA COLLECTED, THE CUSTOMER REPORT OF FALSE NEGATIVE HCG PERFORMANCE FROM CLINITEST HCG LOT 071962 WHEN TESTED ON A CLINITEK STATUS+ INSTRUMENT WAS NOT OBSERVED. THE CAUSE OF THE EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. SIEMENS HAS REQUESTED THE REAGENT BE RETURNED FOR INVESTIGATION. SIEMENS SERVICE REVIEWED PROPER TECHNIQUE AND CLEANING AND MAINTENANCE PROCEDURES. QC IS PASSING AND OPERATORS ARE FOLLOWING PROPER TECHNIQUE. THE CUSTOMER STATED NO TESTS OR PROCEDURES WERE DELAYED DUE TO THE DISCREPANT RESULT. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) URINE HCG RESULT ON THE CLINITEK STATUS+ WHEN COMPARED TO A REPEAT ON THE SAME INSTRUMENT, A REPEAT ON ANOTHER CLINITEK STATUS+ AND A SERUM QUANTITATIVE RESULT. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152532 CLINITEK STATUS+ CLINITEK STATUS+ JHI SIEMENS HEALTHCARE DIAGNOSTICS 10379675 00630414574639

    Patients

    Seq Age Sex Outcome Treatment
    1