BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT HCG DIPSTICK TEST

    MDR report key: 21568394 · Received March 10, 2025

    Report

    Report Number
    2027969-2025-00061
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 15, 2025
    Report Date
    June 19, 2025
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    UDI-DI
    20612479202751
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE CUSTOMER INDICATED THE EVENT TOOK PLACE EITHER 15FEB2025 OR 16FEB2025. D8 - WAS DEVICE SERVICED BY THIRD PARTY? WAS UPDATED FROM BLANK TO "NO". H2, H3, H6 AND H11 WERE UPDATED TO INCLUDE RETURN TESTING. INVESTIGATION CONCLUSION: AN INVESTIGATION WAS PERFORMED ON RETENTION AND RETURN PRODUCTS FROM THE REPORTED LOT NUMBER. RETENTION AND RETURN DEVICES WERE TESTED WITH CLINICAL NEGATIVE URINE SAMPLES AND THE RESULTS WERE READ AT 3 AND 4 MINUTES. ALL DEVICES TESTED WITH CLINICALLY NEGATIVE URINE SAMPLES YIELDED NEGATIVE RESULTS. RETURN DEVICES WERE ADDITIONALLY TESTED USING CUT-OFF STANDARDS (25 MIU/ML), AND HIGH POSITIVE STANDARDS (201.1IU/ML AND 223.3IU/ML). RESULTS WERE READ 3 MINUTES FOR DEVICES TESTED WITH CUT-OFF AND HIGH POSITIVE STANDARD SAMPLES. ALL DEVICES TESTED WITH CUT-OFF AND POSITIVE SAMPLES YIELDED POSITIVE RESULTS. NO FALSE POSITIVE OR NEGATIVE 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 ABNORMALITIES 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 OR RETURN PRODUCT. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE PACKAGE INSERT: - VERY LOW LEVELS OF HCG (LESS THAN 50 MIU/ML) ARE PRESENT IN URINE SPECIMEN SHORTLY AFTER IMPLANTATION. HOWEVER, BECAUSE A SIGNIFICANT NUMBER OF FIRST TRIMESTER PREGNANCIES TERMINATE FOR NATURAL REASONS, A TEST RESULT THAT IS WEAKLY POSITIVE SHOULD BE CONFIRMED BY RETESTING WITH A FIRST MORNING URINE SPECIMEN COLLECTED 48 HOURS LATER. - A NUMBER OF CONDITIONS OTHER THAN PREGNANCY, INCLUDING TROPHOBLASTIC DISEASE AND CERTAIN NON-TROPHOBLASTIC NEOPLASMS INCLUDING TESTICULAR TUMORS, PROSTATE CANCER, BREAST CANCER, AND LUNG CANCER, CAUSE ELEVATED LEVELS OF HCG. THEREFORE, THE PRESENCE OF HCG IN URINE SPECIMEN SHOULD NOT BE USED TO DIAGNOSE PREGNANCY UNLESS THESE CONDITIONS HAVE BEEN RULED OUT. - 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 · 0

    B3 - DATE OF EVENT: THE CUSTOMER INDICATED THE EVENT TOOK PLACE EITHER 15FEB2025 OR 16FEB2025. RESULTS PENDING COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING A FAINT FALSE POSITIVE HCG RESULT WHILE USING THE CONSULT HCG DIPSTICK TEST ON A NON-PREGNANT PATIENT. SPECIFICS WERE NOT PROVIDED AS TO WHY THE PATIENT PRESENTED, HOWEVER THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED USING THE CONSULT HCG DIPSTICK. THE RESULTS WERE READ AT 3 MINUTES AND A FAINT FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A CONSULT HCG URINE CASSETTE WHICH YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING A FAINT FALSE POSITIVE HCG RESULT WHILE USING THE CONSULT HCG DIPSTICK TEST ON A NON-PREGNANT PATIENT. SPECIFICS WERE NOT PROVIDED AS TO WHY THE PATIENT PRESENTED, HOWEVER THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED USING THE CONSULT HCG DIPSTICK. THE RESULTS WERE READ AT 3 MINUTES AND A FAINT FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A CONSULT HCG URINE CASSETTE WHICH YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203394 CONSULT HCG DIPSTICK TEST VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI ALERE SAN DIEGO, INC. FHC-101 0000818406 20612479202751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female