BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT DIAGNOSTICS HCG DIPSTICK

    MDR report key: 2703846 · Received August 15, 2012

    Report

    Report Number
    2027969-2012-01203
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Date of Event
    July 13, 2012
    Report Date
    August 15, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER(S): HCG1110225. EXPIRATION DATE(3): 12/01/2013. CONTROL LOT: 25MIU/ML HCG URINE LOT: HCG120405-01, 202IU/ML HCG URINE LOT: HCG120522-01, 210IU/ML HCG URINE LOT: HCG120229-02, 210.0OIU/ML HCG URINE LOT: HCG120517-01. SUMMARY OF RESULTS: THE RETENTION STRIPS MEET QC SPECIFICATION. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL. (N=15). CLEARLY POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 210.OIU/ML HCG URINE CONTROL. (N=5). CLEARLY POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 210IU/ML HCG URINE CONTROL. (N=5). CLEARLY POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 202IU/ML HCG URINE CONTROL. (N=5). 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 LEVELS WERE TESTED WITH RETAIN PRODUCTS. RESULTS MET QC SPECIFICATION. NO FALSE NEGATIVES WERE OBSERVED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. UNABLE TO IDENTIFY THE ROOT CAUSE WITHOUT PT SPECIMEN ANALYSIS IN-HOUSE. THIS ISSUE WILL BE TRACKED AND TRENDED. TO DATE, ONE COMPLAINT HAS BEEN REPORTED AGAINST THIS LOT. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS WITH CONSULT DIAGNOSTICS HCG DIPSTICK. NO DETAILS WERE PROVIDED BY THE DISTRIBUTOR. CUSTOMER WAS CONTACTED BY EMAIL AND PROVIDED THE CUSTOMER'S (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULT DIAGNOSTICS HCG DIPSTICK HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-101-OBC517 HCG1110225

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR