BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE HCG COMBO CASSETTE (20/10)

    MDR report key: 2719029 · Received August 27, 2012

    Report

    Report Number
    2027969-2012-01251
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    July 30, 2012
    Report Date
    August 27, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    JHI
    PMA / PMN Number
    062361
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT SAMPLES WERE NOT RETURNED FOR INVESTIGATION. PRODUCT SUPPORT TESTED (B)(4) RETAINED DEVICES AT LOW CUT OFF AND (B)(4) RETAINED DEVICES AT HIGH CUT OFF WITH IN-HOUSE CONTROLS. INVESTIGATION RESULTS FOR RETAINED TESTING: CONTROLS: 20 MIU/ML HCG URINE LOT: HCG120130-01; 210.0 IU/ML HCG URINE LOT: HCG120517-01; 202 IU/ML HCG URINE LOT: HCG120522-01; 207 IU/ML HCG URINE LOT: HCG120306-01. SUMMARY OF RESULTS: THE 20 MIU/ML (N=15), 210.0 IU/ML (N=5), 202 IU/ML (N=5) AND 207 IU/ML (N=5) HCG URINE CONTROLS ALL YIELDED CORRECT POSITIVE RESULTS AT 3 MINUTES READING TIME WITH RETENTION DEVICES. CONCLUSION: CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED IN-HOUSE WITH CONTROL SAMPLES. HCG URINE CONTROLS AT CUT OFF AND HIGH LEVELS WERE TESTED WITH RETAINED PRODUCTS. ALL RESULTS MET QC SPECIFICATION. NO FALSE NEGATIVES WERE OBSERVED. NO ABNORMAL FINDING DURING MANUFACTURING DOCUMENT REVIEW. PT WAS PREGNANT WITH TWINS AND HAD A HCG SERUM QUANTITY OF 62,000 MIU/ML. HOOK EFFECT CANNOT BE RULED OUT. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED. AS OF (B)(4) 2012, (B)(4) COMPLAINT HAS BEEN REPORTED AGAINST LOT #HCG1110042. COMPLAINT ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (POINT-OF-CARE COORDINATOR, (POCC)) REPORTED TWO FALSE NEGATIVE URINE HCG RESULTS FOR ONE PT. A (B)(6) PT PRESENTED WITH CHEST PAINS ON (B)(6) 2012. PT SAMPLES WERE COLLECTED AT 21:40 AND 23:30 AND RESULTS WERE NEGATIVE. QUANTITATIVE SERUM HCG RESULT: PLASMA ON SIEMENS RXL = 62,000 MIU/ML. PREGNANCY WAS ALSO CONFIRMED BY ULTRASOUND SHOWING TWINS. NO OTHER PT INFO PROVIDED. TESTING TECHNIQUE: INTERNAL/EXTERNAL CONTROLS: FINE; EXTERNAL CONTROLS REPEATED ON MORNING OF (B)(6) 2012 AND WERE FINE. KIT STORAGE: ROOM TEMPERATURE. READ TIME: POCC INSTRUCTED THE ER STAFF THAT URINE IS 3-4 MINUTES. TIMER USE? POCC DOES NOT SEE A TIMER IN THE ER AREA. AGE OF SPECIMEN AND STORAGE IF APPLICABLE: FRESH. SPECIMEN AT ROOM TEMP WHEN TESTED? NOT SURE. POUCH/CANISTER OPENED JUST PRIOR TO TESTING? NOT SURE. COLOR/CLARITY OF URINE? YELLOW/CLOUDY. IF CLOUDY, WAS IT SPUN DOWN OR ALLOWED TO SETTLE OUT? ER DOES NOT HAVE CAPABILITY TO SPIN SAMPLES; POCC DOES NOT KNOW IF SAMPLE WAS ALLOWED TO SETTLE BEFORE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALERE HCG COMBO CASSETTE (20/10) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC FHC-A202 HCG1110042

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR