BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 9396030 · Received December 2, 2019

    Report

    Report Number
    3002637618-2019-00126
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    October 8, 2019
    Report Date
    December 2, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JHI
    UDI-DI
    00630414574639
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    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 REVIEWED CLEANING AND TECHNIQUE WITH THE CUSTOMER. SIEMENS HAS MADE THREE ATTEMPTS TO REACH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION AND TO REQUEST THE REAGENT CARTRIDGES BACK FOR INVESTIGATION. THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER. THE CAUSE OF THIS EVENT IS UNKNOWN. I AM FILING THIS MDR AT FDA'S REQUEST. THE ORIGINAL MDR (3002637618-2019-00123) WAS FILED UNDER PROCODE JIL. PER THE FDA, THE DEVICE (K091216) HAS MULTIPLE PRODUCT CODES INCLUDING JIL, THEREFORE USING THIS PROCODE IS NOT INCORRECT. THEY ARE RECOMMENDING THAT THIS MDR SHOULD ALSO BE FILED UNDER JHI (HCG) SO THAT THE MDR REVIEWER WITH THE APPROPRIATE EXPERTISE RECEIVES IT AS WELL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE URINE HCG RESULT. AN IUD WAS THEN IMPLANTED IN THE PATIENT. THE PATIENT LATER TOOK A HOME PREGNANCY TEST AND RECEIVED A POSITIVE RESULT. AN ULTRASOUND THEN SHOWED THE PATIENT TO BE 6.5 WEEKS PREGNANT AND THE IUD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190017 CLINITEK STATUS+ CLINITEK STATUS+ JHI SIEMENS HEALTHCARE DIAGNOSTICS 00630414574639

    Patients

    Seq Age Sex Outcome Treatment
    1