BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBECHEK MULTIVYSION CONTROL SLIDES

    MDR report key: 6560231 · Received May 11, 2017

    Report

    Report Number
    3005248192-2017-00002
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 20, 2017
    Report Date
    May 11, 2017
    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

    FIELD 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, (B)(4)- GENERAL PURPOSE REAGENT WAS USED IN E-SUBMITTER. PROBECHEK MULTIVYSION CONTROL SLIDES (LIST NUMBER (B)(4)) IS REGISTERED AND LISTED AS A GENERAL PURPOSE REAGENT WITH A PRODUCT CODE PPM, DEVICE CLASS 1 AND REGULATION NUMBER (B)(4). SUMMARY OF COMPLAINT INVESTIGATION: INVESTIGATION INTO THIS COMPLAINT INCLUDED AN EVALUATION OF THE QUALITY DATA REVIEW, COMPLAINT HISTORY REVIEW, REVIEW OF CUSTOMER IMAGES AND RETAIN SAMPLE EVALUATION. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW NO ERRORS/ISSUES WERE IDENTIFIED. THE PRODUCTS UNDER INVESTIGATION MET QUALITY SPECIFICATIONS AT THE TIME OF RELEASE. A PROCESS REVIEW INDICATED SLIDES ARE INSPECTED AT REGULAR INTERVALS FOR DAMAGE IN THE MANUFACTURING PROCESS AND THAT SLIDES ARE PACKED AND SHIPPED SUFFICIENTLY TO MINIMIZE DAMAGE. RETAIN / FILE SAMPLE EVALUATION: 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. RETURN SAMPLE EVALUATION: THE CUSTOMER'S SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. NOTE THAT BROKEN SLIDES WOULD NOT BE REQUESTED FOR RETURN IN ORDER TO MINIMIZE POTENTIAL HARM TO THE HANDLER. THE CUSTOMER PROVIDED IMAGES. REVIEW OF THE IMAGES INDICATED THAT 1 OF 5 SLIDES WAS BROKEN (BROKEN SLIDE WAS NEAREST TO FRONT LABEL POSITION). COMPLAINT HISTORY REVIEW: FIVE COMPLAINTS REPORTING BROKEN/DAMAGED SLIDES WERE IDENTIFIED FOR THE PAST YEAR. CURRENT COMPLAINT RATE FOR BROKEN SLIDES IS 0.06%, WHICH INDICATES THAT THE ISSUE MAY BE SEEN WITH A FREQUENCY OF "OCCASIONAL". PRODUCT DEFICIENCY DECISION: BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT OR SYSTEMIC DEFICIENCY FOR PROBECHEK MULTIVYSION CONTROL SLIDES LIST# (B)(4) LOT# 473332 HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    (B)(4) DISTRIBUTOR RECEIVED SLIDES FROM ABBOTT MOLECULAR, THEY FOUND THAT 1 BOX OF THE MULTIVYSION CONTROL SLIDE WAS DAMAGED. BASED ON THE IMAGES PROVIDED, AT LEAST ONE SLIDE APPEARED TO BE BROKEN. THERE WAS NO REPORT OF INJURY. THE CERTIFICATE OF ANALYSIS FOR PROBECHEK 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
    342811 PROBECHEK MULTIVYSION CONTROL SLIDES GENERAL PURPOSE REAGENT, PRODUCT CODE: PPM LDT ABBOTT MOLECULAR, INC. 473332

    Patients

    Seq Age Sex Outcome Treatment
    1