BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 1790570 · Received August 2, 2010

    Report

    Report Number
    2027969-2010-01108
    Event Type
    Other
    Date Received
    August 2, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER (S): HCG0020027. EXPT DATE(S): 02/2012. CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG100113-01, 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01, 237.6IU/ML HCG URINE CONTROL LOT: HCG100420-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTE READ TIME (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME (N=5). THE 237.6 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME (N=3). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULT WAS NOT REPLICATED AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECIFICATIONS. VERIFIED THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD; NO ABNORMAL RESULTS WERE FOUND. CUSTOMER'S OBSERVATION COULD NOT BE REPRODUCED IN-HOUSE WITH CONTROL SAMPLES. HCG URINE CONTROLS AT CUTOFF AND HIGH LEVEL WERE TESTED WITH RETAIN DEVICES. UNABLE TO IDENTIFY THE ROOT CAUSE WITHOUT PT SPECIMEN ANALYSIS IN-HOUSE. PRODUCT DEFICIENCY WAS NOT ESTABLISHED; NO CORRECTIVE ACTION REQUIRED AT THIS TIME. CUSTOMER PRODUCT WILL BE TESTED IF IT IS RETURNED.

    Description of Event or Problem · 1

    CALLER REPORTED THAT CUSTOMER HAD A FALSE NEGATIVE URINE HCG RESULT VS SERUM QUANTITATIVE RESULT OF 3160MIU/ML AND POSITIVE HOME PREGNANCY TEST. PER CALLER, PT HAD TESTED USING A HOME PREGNANCY TEST (BRAND UNK) WITH A POSITIVE RESULT. PT THEN HAD A NEGATIVE RESULT WHEN TESTED ON ICON TEST DEVICE. THE SERUM QUANT WAS POSITIVE AT 3160MIU/ML. PT RECEIVED DEPO SHOT. NO OTHER PT INFO PROVIDED. FALSE NEGATIVE RESULTS COULD LEAD TO MISSED DIAGNOSIS OF PREGNANCY. ALTHOUGH NO REPORT OF DEATH OR 'SERIOUS INJURY', A MISSED DIAGNOSIS COULD RESULT IN TREATMENT CONTRAINDICATED IN PREGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY TEST JHI BIOSITE INCORPORATED FHC-202 HCG0020027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other