BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT DIAGNOSTICS HCG CASSETTE

    MDR report key: 2140809 · Received June 15, 2011

    Report

    Report Number
    2027969-2011-01353
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WITH RETAINS: LOT NUMBER: HCG0030251. EXPIRATION DATE: 03/2012. CONTROL LOT: 20MIU/ML HCG URINE LOT: HCG110216-01, 100MIU/ML HCG URINE LOT: HCG110307-01, 278.9IU/ML HCG URINE LOT: HCG110214-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. (N=4). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). THE 278.9IU/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. INVESTIGATION WITH RETURNED DEVICES: LOT NUMBER: HCG0030251. EXPIRATION DATE: 03/2012. CONTROL LOT: 20MIU/ML HCG URINE LOT: HCG110216-01, 100MIU/ML HCG URINE LOT: HCG110307-01, 208.9IU/ML HCG URINE LOT: HCG110216-03. SUMMARY OF RESULTS: THE RETURN DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. (N=2). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=2). THE 208.9IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=2). CONCLUSION: FROM RETURN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULT WAS NOT REPLICATED AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECIFICATIONS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED WHEN TESTING WAS PERFORMED WITH BOTH RETAINED AND RETURNED PRODUCT.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE URINE HCG TEST ON LATERAL FLOW DEVICES. NO SERUM HCG OR ULTRASOUND PERFORMED. FALSE NEGATIVE BASED ON THREE POSITIVE TEST RESULTS ACHIEVED FROM ANOTHER UNKNOWN LATERAL FLOW KIT. PATIENT PRESENTED FOR TESTING AS HOME TEST CAME BACK POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULT DIAGNOSTICS HCG CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A102-OBC554 HCG0030251

    Patients

    Seq Age Sex Outcome Treatment
    1