BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTI-CHECK CD4 LOW CONTROL

    MDR report key: 17560797 · Received August 16, 2023

    Report

    Report Number
    2916837-2023-00170
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    August 2, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903409143
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00170 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.5. PMA / 510(K)#: K150815. 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 THERE WAS A LABELING ISSUE WITH BD MULTI-CHECK CD4 LOW CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTI-CHECK CD4 LOW CONTROL PRODUCT (#340914 BM0823L) BOX CONTAINS ANOTHER PRODUCT, MULTI-CHECK CONTROL (#340911; BM0823N) TUBE, SO COMPLAINTS ARE COMING IN. IT'S BEEN ALLEGED BY ONE OF OUR DISTRIBUTORS AND THE CONFIRMED Q¿TY WAS 5 BOXES. AND IT NEEDS TO CONFIRM WHETHER IT'S JUST A CORRECT PRODUCT (MULTI-CHECK CD4 LOW CONTROL (#340914; BM0823L)) WITH MISLABELED OR OTHER PRODUCTS(MULTI-CHECK CONTROL (#340911; BM0823N) PACKAGED. ALSO PLEASE NOTE THAT THE PRODUCT¿S EXPIRATION PERIOD IS JUST A MONTH, SO MANY CUSTOMERS ARE WORRIED ABOUT THEIR TESTING SCHEDULE, ESPECIALLY IN THE HOSPITALS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH BD MULTI-CHECK CD4 LOW CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTI-CHECK CD4 LOW CONTROL PRODUCT (#340914 BM0823L) BOX CONTAINS ANOTHER PRODUCT, MULTI-CHECK CONTROL (#340911; BM0823N) TUBE, SO COMPLAINTS ARE COMING IN. IT'S BEEN ALLEGED BY ONE OF OUR DISTRIBUTORS AND THE CONFIRMED QTY WAS 5 BOXES. AND IT NEEDS TO CONFIRM WHETHER IT'S JUST A CORRECT PRODUCT (MULTI-CHECK CD4 LOW CONTROL (#340914; BM0823L)) WITH MISLABELED OR OTHER PRODUCTS(MULTI-CHECK CONTROL (#340911; BM0823N) PACKAGED. ALSO PLEASE NOTE THAT THE PRODUCT¿S EXPIRATION PERIOD IS JUST A MONTH, SO MANY CUSTOMERS ARE WORRIED ABOUT THEIR TESTING SCHEDULE, ESPECIALLY IN THE HOSPITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686969 BD MULTI-CHECK CD4 LOW CONTROL COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BM0823L 00382903409143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown