BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBECHEK MULTIVYSION CONTROL SLIDES

    MDR report key: 6133468 · Received November 29, 2016

    Report

    Report Number
    3005248192-2016-00007
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 3, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    LDT
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. FIELD D2 INCLUDES GENERAL PURPOSE REAGENT, PRODUCT CODE: PPM. HOWEVER, THE PRODUCT CODE PPM RESULTED IN AN ERROR CODE (INVALID CODE) BY THE FDA E-SUBMITTER SOFTWARE IN THE DEVICE PRODUCT CODE SECTION. AS A RESULT, PRODUCT CODE LDT, REAGENT, GENERAL PURPOSE, CLASS I, PATHOLOGY, 864.4010 - GENERAL PURPOSE REAGENT, WAS USED IN E-SUBMITTER. PROBECHEK MULTIVYSION CONTROL SLIDES (LIST NUMBER 05J07-001) IS REGISTERED AND LISTED AS A GENERAL PURPOSE REAGENT WITH A PRODUCT CODE PPM, DEVICE CLASS 1 AND REGULATION NUMBER 864.4010.

    Additional Manufacturer Narrative · 1

    SUMMARY OF THE COMPLAINT INVESTIGATION FOR MDR 3005248192-2016-00007. THE INVESTIGATION INCLUDED REVIEW OF QUALITY DATA, INSPECTION OF ABBOTT MOLECULAR (AM) RETENTION SAMPLES FROM THE LOTS IN QUESTION, AND COMPLAINT HISTORY REVIEW. RELATED MANUFACTURING AND TEST RECORDS WERE REVIEWED, AND NO ERRORS WERE IDENTIFIED. THE MANUFACTURING PROCESS IS A MANUAL PROCESS. SLIDES ARE 100% INSPECTED AT THE KIT MANUFACTURING STAGE FOR SPECIFIC ISSUES INCLUDING DAMAGE. ONCE PLACED INTO KITS, THE KITS ARE SAMPLED AND INSPECTED BY QUALITY CONTROL (QC). NO ISSUES WERE NOTED DURING INSPECTION. IN ADDITION, A PROCESS IS IN PLACE TO MINIMIZE DAMAGE DURING SHIPMENT OF SLIDES FROM AM. A VISUAL INSPECTION USING AM RETAIN SAMPLES FROM THE SAME LOTS OF MATERIAL IN QUESTION WAS PERFORMED TO DETERMINE IF PRODUCTS HAD ANY VISUALLY IDENTIFIABLE DAMAGE. NO DAMAGE WAS IDENTIFIED. ASIDE FROM THE COMPLAINT CURRENTLY BEING ADDRESSED BY THIS INVESTIGATION, THREE ADDITIONAL COMPLAINTS REPORTING BROKEN/DAMAGED SLIDES WAS REPORTED IN THE LAST 12 MONTHS. THE CURRENT COMPLAINT RATE FOR BROKEN SLIDES IS 0.05%, WHICH INDICATES THAT THE ISSUE MAY BE SEEN WITH A FREQUENCY OF "OCCASIONAL." BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT OR SYSTEMIC DEFICIENCY FOR PROBECHEK MULTIVYSION CONTROL SLIDES HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    (B)(4) DISTRIBUTOR RECEIVED 1 BOX OF PROBECHEK MULTIVYSION CONTROL SLIDES THAT HAD BROKEN SLIDES IN IT. ADDITIONALLY, IT APPEARED THAT THERE WAS DAMAGE TO THE OUTER SHIPPING PACKAGE. THERE WAS NO REPORT OF INJURY. THE CERTIFICATE OF ANALYSIS FOR PROBECHECK MULTIVYSION CONTROL SLIDES INDICATES THESE SLIDES CONTAIN HUMAN SOURCED AND /OR POTENTIALLY INFECTIOUS COMPONENTS. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783732 PROBECHEK MULTIVYSION CONTROL SLIDES GENERAL PURPOSE REAGENT, PRODUCT CODE: PPM, LDT ABBOTT MOLECULAR, INC. 472262

    Patients

    Seq Age Sex Outcome Treatment
    1