BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE

    MDR report key: 3196026 · Received June 21, 2013

    Report

    Report Number
    2027969-2013-00496
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 4, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    MVO
    Removal / Correction Number
    2027969-06/03/13-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS 510K EXEMPT FOR FORENSIC USE ONLY. INVESTIGATION: THE LOT NUMBER, PRODUCT NUMBER AND PRODUCT DESCRIPTION WERE VERIFIED. THE DEVICES WERE NOT RETURNED FOR INVESTIGATION. EVALUATION OF THE RETAIN SAMPLES CONFIRMED THE CUSTOMER'S COMPLAINT. A REVIEW OF ALL LOTS WITHIN A 2 YEAR SHELF-LIFE WAS CONDUCTED. CAPA (B)(4) WAS OPENED FOR THIS ISSUE. THE FOLLOWING CASE WAS REPORTED UNDER A SEPARATE MEDWATCH FROM. CASE NUMBER: (B)(4); LOT NUMBER: DOA2110316/B121003/B12001; MEDWATCH FORM: 2027969-2013-00497.

    Description of Event or Problem · 1

    CALLER ALLEGED THAT THE MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE SPONGE DISLODGED FROM THE COLLECTOR HANDLE WHILE COLLECTING ORAL FLUID SPECIMENS. THIS DEVICE IS FOR FORENSIC USE ONLY. INFO REPORTED AS FOLLOWS: DATE: (B)(6) 2013; CASE NUMBER: (B)(4); LOT NUMBER DOA2110317/B21003; QUANTITY: 7. ON (B)(6) 2013; (B)(4); DOA2110317/B21003; 30. ON (B)(6) 2013; (B)(4); DOA2110317/B21003; 25. ON (B)(6) 2013; 00456614; DOA2110317/B21003; 5 AND ON (B)(6) 2013; (B)(4); DOA2110317/B21003; 85. THE FOLLOWING CASE WAS REPORTED UNDER A SEPARATE MEDWATCH FORM. DATE: (B)(6) 2013; CASE NUMBER: (B)(4); LOT NUMBER DOA2110316/B21003/B121001; QUANTITY: 15. THERE WERE NO REPORTED ADVERSE PT SEQUELA. THERE WERE NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284042 REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE DRUGS OF ABUSE TEST MVO ALERE SAN DIEGO, INC DSD-765-011-OBC06 DOA2110317/B21003

    Patients

    Seq Age Sex Outcome Treatment
    1