BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN HCG URINE CASSETTE 25T

    MDR report key: 6055979 · Received October 25, 2016

    Report

    Report Number
    2027969-2016-00664
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    September 28, 2016
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION. INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION OR RETURN PRODUCTS. RETENTION AND RETURN PRODUCTS WERE TESTED WITH 25MIU/ML HCG URINE CONTROL AND 3 HIGH LEVELS OF HCG URINE CONTROLS. ALL PRODUCTS SHOWED HCG POSITIVE RESULTS AT READ TIME AND MET QC SPECIFICATIONS. NO FALSE NEGATIVE RESULTS WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED BY CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED OF FALSE NEGATIVE URINE HCG ON HENRY SCHEIN ONE STEP URINE CASSETTE. CALLER ALLEGES FALSE NEGATIVE RESULTS WERE RECEIVED FOR FOUR (4) PATIENTS. ALTHOUGH REQUESTED NUMEROUS TIMES, NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. CONFIRMATORY METHOD, IF ANY, NOT PROVIDED. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706594 HENRY SCHEIN HCG URINE CASSETTE 25T HCG PREGNANCY TEST JHI FHC-102-KHS25 HCG5120243

    Patients

    Seq Age Sex Outcome Treatment
    1