BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT HCG URINE CASSETTE

    MDR report key: 16092358 · Received January 3, 2023

    Report

    Report Number
    2027969-2023-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    November 9, 2022
    Report Date
    January 3, 2023
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: RETAINED DEVICES FROM THE REPORTED LOT NUMBERS WERE TESTED WITH HCG-NEGATIVE CLINICAL URINE SAMPLES. THE RESULTS WERE READ AT 3 MINUTES AND ALL DEVICES YIELDED THE EXPECTED NEGATIVE RESULTS. NO FALSE POSITIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES AND FOUND THAT THE LOT MET QUALITY CONTROL SPECIFICATIONS. REVIEW OF THE RISK MANAGEMENT REPORT FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION AS THE REPORTED ISSUE WAS NOT REPLICATED DURING TESTING OF RETENTION PRODUCT. PER THE PACKAGE INSERT: VERY LOW LEVELS OF HCG (LESS THAN 50 MIU/ML) ARE PRESENT IN URINE SPECIMENS SHORTLY AFTER IMPLANTATION. HOWEVER, BECAUSE A SIGNIFICANT NUMBER OF FIRST TRIMESTER PREGNANCIES TERMINATE FOR NATURAL REASONS, A TEST RESULT THAT IS WEAKLY POSITIVE SHOULD BE CONFIRMED BY RETESTING WITH A FIRST MORNING URINE SPECIMEN COLLECTED 48 HOURS LATER. AS WITH ANY ASSAY EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SPECIMEN. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HAMA. SUCH SPECIMENS MAY CAUSE FALSE POSITIVE OR FALSE NEGATIVE RESULTS. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED. ALTHOUGH REQUESTED, THE PRODUCT IS NOT EXPECTED TO BE RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING WITH CONSULT HCG URINE CASSETTES. CONFIRMATORY HCG BLOOD WORK WAS PERFORMED WITH NEGATIVE RESULTS. NO ADVERSE OUTCOMES WERE REPORTED. THE CUSTOMER HAD THE FOLLOWING FOUR LOTS OF CONSULT HCG URINE CASSETTES IN USE AT THE FACILITY: HCG2012065 - (01)20612479202744(17)240131(10)HCG2012065 HCG2032022 - (01)20612479202744(17)240229(10)HCG2032022 HCG2012018 - (01)20612479202744(17)231231(10)HCG2012018 HCG2012019 - (01)20612479202744(17)240131(10)HCG2012019 IT IS UNCLEAR HOW MANY INCIDENTS, IF ANY, OCCURRED WITH EACH LOT. ALTHOUGH REQUESTED, NO FURTHER DETAILS OR CLARIFICATION WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470870 CONSULT HCG URINE CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A102

    Patients

    Seq Age Sex Outcome Treatment
    1 Female