BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT HCG DIPSTICK TEST 5000 25T

    MDR report key: 6181864 · Received December 16, 2016

    Report

    Report Number
    2027969-2016-00704
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 30, 2016
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION PRODUCTS OF THE REPORTED LOT. RETENTION DEVICES WERE TESTED IN-HOUSE WITH 25 MIU/ML HCG URINE CUTOFF CONTROLS AND 3 HIGH-LEVEL HCG URINE CONTROLS. ALL RESULTS WERE HCG-POSITIVE AT THE READ TIME AND MET THE QC SPECIFICATION. FALSE NEGATIVE RESULTS WERE NOT OBSERVED DURING IN-HOUSE INVESTIGATION. A REVIEW OF MANUFACTURING BATCH RECORDS DID NOT UNCOVER ANY ABNORMALITIES. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    REPORT RECEIVED OF FALSE NEGATIVE URINE HCG RESULTS RECEIVED ON CONSULT HCG DIPSTICK TEST 5000 25T. PATIENT'S LMP UNKNOWN. PATIENT EXHIBITING EARLY SIGNS OF PREGNANCY. (B)(6). NO PROCEDURE/TREATMENT PERFORMED BASED ON DISCREPANT RESULTS. CURRENT STATUS OF PATIENT IS UNKNOWN. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832725 CONSULT HCG DIPSTICK TEST 5000 25T HCG PREGNANCY TEST JHI FHC-101 HCG6040183

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR