BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-DRUG ONE STEP MULTI-LINE 11 DRUG SCREEN TEST DEVICE (URINE)

    MDR report key: 10935868 · Received December 2, 2020

    Report

    Report Number
    2027969-2020-00079
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 14, 2021
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    LFG
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6 TYPE OF INVESTIGATION: 4119 INSUFFICIENT INFORMATION AVAILABLE. INVESTIGATION CONCLUSION: THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. RETAIN TESTING AND MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AS NEITHER A LOT NUMBER NOR THE SPECIFIC PRODUCT USED COULD BE OBTAINED. A RISK REVIEW WAS PERFORMED AND THIS ISSUUE IS ANTICIPATED IN NATURE. THE SEVERITY AND PROBABILITY OF OCCURRENCE ARE WITHIN THE RISK PROFILE OF THE DEVICE. A ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE PACKAGE INSERT: THE MULTI-DRUG ONE STEP MULTI-LINE SCREEN TEST DEVICE (URINE) PROVIDES ONLY A QUALITATIVE, PRELIMINARY ANALYTICAL RESULT. A SECONDARY ANALYTICAL METHOD MUST BE USED TO OBTAIN A CONFIRMED RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. THERE IS A POSSIBILITY THAT TECHNICAL OR PROCEDURAL ERRORS, AS WELL AS OTHER INTERFERING SUBSTANCES IN THE URINE SPECIMEN MAY CAUSE ERRONEOUS RESULTS. A NEGATIVE RESULT MAY NOT NECESSARILY INDICATE DRUG-FREE URINE. NEGATIVE RESULTS CAN BE OBTAINED WHEN DRUG IS PRESENT BUT BELOW THE CUT-OFF LEVEL OF THE TEST.

    Additional Manufacturer Narrative · 1

    CUSTOMER TO MONITOR-TROUBLESHOOTING PROVIDED. RESULTS PENDING INVESTIGATION.

    Description of Event or Problem · 1

    (B)(6) 2020: POTENTIAL FALSE NEGATIVE TCA RESULT ON THE SURESTEP MULTI-DRUG ONE STEP SCREEN TEST PANEL. CUSTOMER REPORTS THERE WAS A FAINT LINE FOR TCA WHEN TESTING A PATIENT SAMPLE USING THE SURESTEP MULTI-DRUG ONE STEP SCREEN TEST PANEL, INDICATING A FAINT NEGATIVE RESULT. THE PATIENT WAS ALSO TESTED ON AN ALTERNATE BRAND OF TEST KIT (BRAND AND SPECIFICITY NOT PROVIDED) AND NO LINE WAS OBSERVED, INDICATING A POSITIVE RESULT. THE CUSTOMER ALSO REPORTED A POSITIVE MORPHINE RESULT ON THE SURESTEP MULTI-DRUG ONE STEP SCREEN TEST PANEL AND NEGATIVE ON AN ALTERNATE TEST KIT (BRAND AND SPECIFICITY NOT PROVIDED). NO ADVERSE OUTCOMES REPORTED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402307 MULTI-DRUG ONE STEP MULTI-LINE 11 DRUG SCREEN TEST DEVICE (URINE) DRUG SCREEN LFG ALERE SAN DIEGO, INC. DOA-1115 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly