BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT HCG URINE CASSETTE 5001 25T

    MDR report key: 8976505 · Received September 9, 2019

    Report

    Report Number
    2027969-2019-00353
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Report Date
    November 25, 2019
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    UDI-DI
    20612479202744
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D3: EMAIL: (B)(6). G1/G2: FIRST NAME: (B)(6). LAST NAME: (B)(6). PHONE NUMBER: (B)(6). G5: 510K NUMBER K062361. INVESTIGATION CONCLUSION: AN INVESTIGATION WAS PERFORMED ON RETAINED PRODUCTS FROM THE REPORTED LOT NUMBER. RETAINED DEVICES WERE TESTED WITH QC CUT-OFF STANDARD (20 MIU/ML) AND HIGH HCG-POSITIVE CLINICAL URINE (209.16-228.15 IU/ML). RESULTS WERE READ AT 3 MINUTES AND ALL DEVICES PRODUCED EXPECTED POSITIVE RESULTS. NO FALSE NEGATIVE 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. BATCH RECORD REVIEW FOUND NO RELEVANT NON-CONFORMANCES; THE LOT MET ALL FINAL RELEASE 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. THE REPORTED ISSUE WAS NOT REPLICATED AS RETAINED PRODUCT PERFORMED AS EXPECTED. A ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. AS STATED IN THE PRODUCT INSERT, VERY DILUTE URINE SPECIMENS, AS INDICATED BY A LOW SPECIFIC GRAVITY, MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG. FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST. WHEN PREGNANCY IS STILL SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48 HOURS LATER AND TESTED. 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 CUSTOMER REPORTED RECEIVING FALSE NEGATIVE RESULTS ON THE CONSULT HCG URINE CASSETTE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770100 CONSULT HCG URINE CASSETTE 5001 25T HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A102 HCG9030025 20612479202744

    Patients

    Seq Age Sex Outcome Treatment
    1