BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE HCG URINE CASSETTE

    MDR report key: 11120201 · Received January 5, 2021

    Report

    Report Number
    2027969-2021-00006
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 15, 2021
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    UDI-DI
    30888277191871
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: RETAINED DEVICES FROM THE REPORTED LOT NUMBER WERE TESTED WITH LOW-HCG (3 MIU/ML) AND HCG-NEGATIVE CLINICAL URINE SAMPLES. THE RESULTS WERE READ AT 3 AND 4 MINUTES AND ALL DEVICES YIELDED VALID NEGATIVE RESULTS WITH STRONG CONTROL LINES. NO FALSE POSITIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES AND FOUND THAT THE LOT MET QUALITY CONTROL SPECIFICATIONS. REVIEW OF THE RISK MANAGEMENT REPORT FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION AS THE REPORTED ISSUE WAS NOT REPLICATED DURING TESTING OF RETENTION PRODUCT. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE PACKAGE INSERT, THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED.

    Additional Manufacturer Narrative · 1

    PRODUCT DISCARDED/EXPENDED BY CUSTOMER RESULTS. PENDING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020: PATIENT PRESENTED TO FACILITY FOR AN IUD INSERTION. A PATIENT URINE SAMPLE WAS TESTED ON THE MEDLINE HCG URINE CASSETTE KIT AND A FALSE POSITIVE RESULT WAS OBTAINED 2X. CONFIRMATORY SERUM HCG QUANT PROVIDED A NEGATIVE RESULT OF 1 MIU/ML. THE IUD INSERTION IS CONSIDERED AN ELECTIVE PROCEDURE AND WAS PERFORMED THE SAME DAY AFTER OBTAINING THE NEGATIVE SERUM HCG QUANT RESULT. NO ADVERSE OUTCOMES WERE REPORTED. MEDICATIONS: ZOLOFT, PNV FE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16594 MEDLINE HCG URINE CASSETTE PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102 HCG0032095 30888277191871

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR PNV FE| ZOLOFT