BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT HCG DIPSTICK TEST 5000 25T

    MDR report key: 6110109 · Received November 17, 2016

    Report

    Report Number
    2027969-2016-00683
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    November 3, 2016
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION PRODUCTS. RETENTION PRODUCTS WERE TESTED WITH 25 MIU/ML AND 100 MIU/ML HCG URINE CONTROLS. RETENTION PRODUCTS SHOWED HCG POSITIVE RESULTS AT READ TIME FOR BOTH THE CONTROLS AND MET QC SPECIFICATIONS. NO FALSE NEGATIVE RESULTS WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE HCG RESULT FOR A PATIENT USING A CONSULT HCG DIPSTICK TEST 5000 25T AS COMPARED TO A POSITIVE QUANTITATIVE HCG RESULT OF 451 MIU/ML. THE URINE SAMPLE COLLECTED FOR THE CONSULT HCG DIPSTICK TEST WAS NOT A FIRST MORNING URINE SAMPLE. THE FALSE NEGATIVE HCG RESULT OCCURRED APPROXIMATELY TWO WEEKS PRIOR TO THE DATE OF THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE PER THE CUSTOMER. THE TIMING BETWEEN THE TWO TESTS IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760515 CONSULT HCG DIPSTICK TEST 5000 25T HCG PREGNANCY TEST JHI FHC-101-OBC517 HCG6040183

    Patients

    Seq Age Sex Outcome Treatment
    1