BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE ISCREEN COT COTININE OFD TEST

    MDR report key: 9267755 · Received November 1, 2019

    Report

    Report Number
    2027969-2019-00599
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    October 23, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES TO SECTION H6: METHOD CODE 11 ADDED; RESULTS CODE 213 ADDED; CONCLUSIONS CODE 67 ADDED. INVESTIGATION CONCLUSION: AN INVESTIGATION WAS PERFORMED ON RETENTION PRODUCTS FROM THE REPORTED LOT NUMBER. RETENTION DEVICES WERE TESTED WITH IN-HOUSE DONORS. NONE OF THE DONORS EXHIBITED AN ALLERGIC REACTION DURING THE INVESTIGATION. THE TESTING RESULTS INDICATED THAT ALL COT STRIPS YIELDED CORRECT NEGATIVE RESULTS ON IN-HOUSE DRUG-FREE DONOR SALIVA. THE PRODUCT PERFORMED AS EXPECTED. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. BATCH RECORD REVIEW FOUND NO RELEVANT NON-CONFORMANCES; THE LOT MET ALL FINAL RELEASE 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. THE SAFETY DATA SHEET FOR THE COLLECTION SPONGE, WHICH IS COMPOSED OF FORMALIZED POLYVINYL ALCOHOL (PVA) AND GLYCERIN, DID NOT IDENTIFY ANY HAZARDS. THE REPORTED COMPLAINT WAS NOT REPLICATED. A PROBABLE CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    RESULTS PENDING INVESTIGATION CONCLUSION. DEVICES NOT RETURNED. PRODUCT DISCARDED/EXPENDED BY CUSTOMER.

    Description of Event or Problem · 1

    (B)(6) 2019: PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE SPONGE USED WITH THE ALERE ISCREEN COTININE ORAL FLUID TEST. PATIENT WAS ADMINISTERED 25 MG OF BENEDRYL AND THE SWELLING SUBSIDED. CUSTOMER STATES PATIENT SEEMS TO BE FINE AFTER MEDICATION WAS ADMINISTERED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060972 ALERE ISCREEN COT COTININE OFD TEST COTININE DRUG SCREEN MRS ALERE SAN DIEGO, INC. DCT-B702 COT9040007

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other