BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE)

    MDR report key: 19011092 · Received April 1, 2024

    Report

    Report Number
    3005641941-2024-00003
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    January 1, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ABON BIOPHARM (HANGZHOU) CO., LTD.
    Product Code
    LFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. BASED ON THE FURTHER INFORMATION OVER THE PHONE FROM CUSTOMER, NO PATIENT INFO WAS SHARED AND NO NEGATIVE IMPACT. HOWEVER, CONSIDERING FALSE NEGATIVE OF TCA (TRICYCLIC ANTIDEPRESSANTS) WOULD BE LIKE TO CONTRIBUTE TO A SERIOUS INJURY OR DEATH, THIS MDR IS BEING SUBMITTED CONSERVATIVELY. 2. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE) WITH DRUG OF TCA, MARKETED IN INDIA, WHICH IS SAME/SIMILAR TO ONE-STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD/DEVICE MARKETED IN THE US UNDER 510(K) K023946 WITH DRUG OF TCA. MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE) WITH DRUG OF TCA AND ONE-STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD/DEVICE MARKETED IN THE US UNDER 510(K) K023946 WITH DRUG OF TCA USE DIFFERENT PRODUCT NAMES, BUT SHARE THE SAME INTERNAL CATALOGUE DTC-101A BECAUSE OF SAME FORMULATION. SO THEY ARE CONSIDERED AS SIMILAR PRODUCTS. 3. THE DATE INDICATED IN B3 - DATE OF EVENT CONFIRMED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. ON 04 MARCH 2024 CUSTOMER SAID VIA PHONE THAT THEY ARE FACING THE ISSUE FOR THE LAST 2 MONTHS, SO USE THE 1ST DAY OF JANUARY 2024. 4. INVESTIGATION SUMMARY: THE BATCH RECORD WAS REVIEWED AND NO DEVIATION AS OBSERVED. THE RETAIN PRODUCT WAS PERFORMED AND NO FALSE NEGATIVE RESULT WAS OBSERVED.

    Description of Event or Problem · 0

    CUSTOMER EMAILED TO TELL THAT THEY ARE FACING ISSUE WITH THE DOA-1124 WITH LOT NUMBER OF: 0000724472. THE COMPLIANT STATED THE FAULTY RESULT BEING PRODUCED FOR TCA(TRICYCLIC ANTIDEPRESSANTS). THE RESULTS SO PRODUCED ARE CONSISTENTLY VAGUE AS THE LINE PRODUCED IN EACH CASSETTE FOR TCA IS VERY FAINT LEADING TO CONFUSION AS TO WHETHER POSITIVE OR NEGATIVE. ACCORDING TO THE FURTHER INFORMATION VIA PHONE, NO PATIENT INFORMATION WAS SHARED AND NO NEGATIVE IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361123 MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE) Radioimmunoassay, tricyclic antidepressant drugs LFG ABON BIOPHARM (HANGZHOU) CO., LTD. 0000724472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown