BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTI-CHECK¿

    MDR report key: 17401273 · Received July 26, 2023

    Report

    Report Number
    2916837-2023-00151
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 11, 2023
    Report Date
    April 29, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903409129
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131 G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). H.6 - ANNEX F ANNEX CODE - F26. H.6 INVESTIGATION SUMMARY: ¿ BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF MISSING LABELING WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: ¿ NO PHOTO WAS PROVIDED WITH THE REPORT, WHICH WAS SUBMITTED FOR A MISSING PRODUCT INFORMATION FLYER. ¿ RETAINED KITS WERE VISUALLY INSPECTED INCLUDING THE PRODUCT INFORMATION FLYER. ¿ BHR DOCUMENTATION FOR 340912-BM0623N WAS REVIEWED AT BDB AND BY THE SUPPLIER DURING THE EXECUTION OF SUPPLIER CORRECTIVE ACTION. ¿ THE POTENTIAL CAUSE WAS IDENTIFIED AS LACK OF TRAINING AND INADEQUATE LINE CLEARANCE PERTAINING TO THE MANUFACTURING PROCESS. ISSUE WAS RESOLVED BY PROVIDING CUSTOMER THE MISSING INSERT ASSAY VALUES. ¿ COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510(K)#: K961610. G.5. PMA / 510(K )#: K982231. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL WAS MISSING FROM THE BD MULTI-CHECK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO REFERENCE VALUES PROVIDED NO ASSAY VALUES AND EXPECTED RANGES WERE PROVIDED WITH THE PRODUCT, CUSTOMER IS ASKING FOR THESE. COULD YOU PLEASE CLARIFY IF PART OF THE LABEL WAS MISSING OR IF THE INFORMATION IS INCORRECT ON THE LABEL? YES THAT IS CORRECT, THIS WAS MISSING FROM THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL WAS MISSING FROM THE BD MULTI-CHECK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO REFERENCE VALUES PROVIDED. NO ASSAY VALUES AND EXPECTED RANGES WERE PROVIDED WITH THE PRODUCT, CUSTOMER IS ASKING FOR THESE. COULD YOU PLEASE CLARIFY IF PART OF THE LABEL WAS MISSING OR IF THE INFORMATION IS INCORRECT ON THE LABEL? YES THAT IS CORRECT, THIS WAS MISSING FROM THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646164 BD MULTI-CHECK¿ COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BM0623N 00382903409129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown