BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG COMBO DEVICE SP BRAND RAPID TEST

    MDR report key: 2220004 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01536
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT 20MIU/ML, HCG URINE LOT# HCG110216-01, 100MIU/ML, HCG URINE LOT# HCG110307-01, 260.1IU/ML, HCG URINE LOT: HCG110218-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: DETAILS AS CT 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 MINUTES READ TIME. (N=4). THE 260.1IU/ML, HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READ TIME. (N=4). 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. UNABLE TO IDENTIFY THE ROOT CAUSE WITHOUT PT SPECIMEN ANALYSIS IN-HOUSE. THIS ISSUE WILL BE TRACKED AND TRENDED. NO PRODUCT DEFICIENCY WAS ESTABLISHED; NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE URINE HCG VS SERUM RESULT USING TXL DIMENSION ON PT FOLLOWING A MISCARRIAGE. THE CALLER HAD QUESTIONS REGARDING THE HALF-LIFE OF HCG IN SERUM VS URINE. THERE WERE THREE INCIDENTS WHERE A PT WHO MISCARRIED IN MARCH HAD A SERUM HCG OF MORE THAN 80MIU/ML AND THE URINE PREGNANCY TEST WAS NEGATIVE. THE CALLER ALSO STATED THAT THERE WERE OTHER DISCREPANT RESULTS ON TWO OTHER PTS BUT NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCG COMBO DEVICE SP BRAND RAPID TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202-OBW515 HCG1010096

    Patients

    Seq Age Sex Outcome Treatment
    1