BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERU)

    MDR report key: 3942091 · Received March 4, 2014

    Report

    Report Number
    2027969-2014-00180
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 13, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH CUTOFF (25 MIU/ML) HCG URINE CONTROLS. ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBSERVED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. CUSTOMER REPORTED SERUM BHCG WAS 72 IU/L. HCG CONCENTRATION IN URINE IS USUALLY LOWER THAN IN SERUM. PATIENT'S HCG LEVELS IN URINE MAY HAVE BEEN BELOW CUTOFF. UNABLE TO DETERMINE ROOT CAUSE WITHOUT PATIENT SPECIMEN IN-HOUSE ANALYSIS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS ON ONE PATIENT'S URINE SAMPLE WITH HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM) WHEN COMPARED TO SERUM QUANTITATIVE TEST. (B)(6) 2014: TEST 1 - URINE HCG TEST - NEGATIVE; SERUM BHCG RESULT = 33IU/L. (B)(6) 2014: TEST 2 - URINE HCG REPEATED = FAINT LINE, (B)(6) 2014: TEST 3 - URINE HCG REPEATED = POSITIVE. RESULT; SERUM RESULT = 33.60IU/L ON ONE LAB ANALYZER; SERUM TEST REPEATED RESULT = 34.48 IU/L; BETA HCG ON URINE SAMPLE = 34.24IU/L. (B)(6) 2014: URINE HCG REPEATED WITH NEGATIVE RESULT; SERUM BETA HCG TEST RESULT = 72IU/L. NO FURTHER PATIENT INFORMATION AVAILABLE. THE DISTRIBUTOR REP ALSO ASKED IF THE PATIENT WAS CONFIRMED PREGNANT BUT THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129562 HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERU) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202F-ONW01 HCG3050056

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR