BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW HCG URINE CASSETTE

    MDR report key: 1377554 · Received March 5, 2009

    Report

    Report Number
    2027969-2009-00086
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 5, 2009
    Manufacturer
    BIOSITE INC.
    Product Code
    JHI
    PMA / PMN Number
    993317
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT: 100MIU/ML HCG URINE CONTROL, LOT: HCG081008-01; 25MIU/ML HCG URINE CONTROL, LOT: HCG080821-03; 240.0IU/ML HCG URINE CONTROL, LOT: HCG081231-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL. THE 100MIU/ML AND 240.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. CONCLUSION: THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS OT CONFIRMED. NOTHING ABNORMAL FOUND IN BATCH REVIEW, AND THE PRODUCT NUMBER, PRODUCT DESCRIPTION AND LOT NUMBER WAS VERIFIED. NO CORRECTIVE ACTION REQUIRED, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    ON 02/12/2009: CUSTOMER REPORTS FALSE NEGATIVE HCG RESULTS ON CLEARVIEW HCG PREGNANCY TEST. IN 2008: CLEARVIEW HCG URINE CASSETTE 7070004 NEGATIVE (NOT FIRST A.M. VOID). IN 2009: CLEARVIEW HCG URINE CASSETTE 7080229 NEGATIVE (NOT FIRST A.M. VOID), PREGNANCY WAS SUSPECTED. TWO WEEKS LATER: CLEARVIEW HCG URINE CASSETTE 7050020 POSITIVE. PATIENT THOUGHT TO BE 10 WEEKS PREGNANT UPON EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW HCG URINE CASSETTE HCG PREGNANCY TEST JHI BIOSITE INC. 92217 HCG7070004

    Patients

    Seq Age Sex Outcome Treatment
    1 NI