BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH RAPID TEST HCG COMBO 30T

    MDR report key: 8584985 · Received May 6, 2019

    Report

    Report Number
    2027969-2019-00082
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    UDI-DI
    20885380020268
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETENTION DEVICES FOR THE REPORTED LOT WERE TESTED WITH CLINICAL NEGATIVE SERUM SAMPLES. ALL DEVICES YIELDED EXPECTED NEGATIVES RESULTS AT 5 AND 6 MINUTES. MANUFACTURING BATCH RECORDS OF THE FINAL-PRODUCT, RELEVANT PRODUCT COMPONENTS, AND QUALITY CONTROL RELEASE DATA WERE REVIEWED. NO RELEVANT NON-CONFORMANCES, DEVIATIONS, OR ABNORMALITIES WERE FOUND. ALL QUALITY CONTROL SPECIFICATIONS WERE MET. RETENTION PRODUCTS PERFORMED AS EXPECTED DURING IN-HOUSE TESTING AND COULD NOT REPLICATE THE REPORTED COMPLAINT. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. DUE TO THE VARYING QUALITY OF PHOTOGRAPHS THE POTENTIAL DISCREPANCIES BETWEEN WHAT IS SEEN IN PERSON AND THROUGH A PHOTO MAY AFFECT THE RESULTS. THEREFORE, THESE RESULTS WILL NOT BE EVALUATED BY THE MANUFACTURER. ADDITIONALLY, WHEN TESTING SAMPLES WITH HCG CONCENTRATIONS NEAR THE LEVEL OF DETECTION OF THE DEVICE, SOME VARIABILITY MAY OCCUR. PER THE PACKAGE INSERT, 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE PRE-SURGICAL PATIENT HAD THEIR SERUM SAMPLE TESTED ON THE CARDINAL HEALTH RAPID TEST HCG COMBO AND RECEIVED A FALSE POSITIVE RESULT. WHEN THE SERUM SAMPLE WAS RUN ON THE VITROS, A SERUM QUANT RESULT OF 8 MIU/ML WAS OBTAINED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE PATIENT WAS NOT TREATED BASED ON THE HCG RAPID RESULT. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED ON POTENTIAL SOURCES OF ERROR AND REFERENCED THE PI'S LIMITATIONS SECTION: 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378256 CARDINAL HEALTH RAPID TEST HCG COMBO 30T HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202 HCG8090022 20885380020268

    Patients

    Seq Age Sex Outcome Treatment
    1