BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG COMBO DEVICE SP BRAND RAPID TEST

    MDR report key: 4974721 · Received August 5, 2015

    Report

    Report Number
    2027969-2015-00569
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 12, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH 20 MIU/ML HCG URINE CUTOFF CONTROL AND 100 MIU/ML HCG CONTROL, ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED 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.

    Description of Event or Problem · 1

    RECEIVED AN EMAIL FROM DISTRIBUTOR ALLEGING FALSE NEGATIVE HCG: COURSE OF EVENTS: HOME PREGNANCY TEST (B)(6) 2015 WAS POSITIVE. (LMP (B)(6) 2015). BLEEDING FOR SEVERAL DAYS, ACTIVE BLEED UPON PRESENTATION TO THE EMERGENCY DEPARTMENT (B)(6) 2015. ABDOMINAL ULTRASCAN SHOWED NO DEFINITIVE INTRAUTERINE PREGNANCY, NOT ECTOPIC. NO MEDS ON FILE. (B)(6) 2015 4:11PM, URINE RAPID=NEGATIVE, BETA HCG=163 (KIT LOT NUMBER HCG4080261) WITH "POC URINE PREG NEGATIVE. BUT THEN REPEAT WITH FAINTLY POSITIVE RESULTS." PATIENT REPRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2015 FOR (B)(6) TREATMENT. VAGINAL BLEEDING HAD STOPPED. (B)(6) 2015 2:35PM, URINE RAPID=NEGATIVE (ACCURATE LOT # NOT PROVIDED)., BETA HCG=254. CHART = "NO SONOGRAPHIC EVIDENCE OF INTRAUTERINE GESTATION SAC. COULD BE ECTOPIC." SERUM BETA HCG QUANT = 254 MIU/ML. DIAGNOSIS = "VAGINAL BLEEDING, PREGNANCY FIRST TRIMESTER WITH UTI." NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519137 HCG COMBO DEVICE SP BRAND RAPID TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202-OBW515

    Patients

    Seq Age Sex Outcome Treatment
    1