BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 14323772 · Received May 7, 2022

    Report

    Report Number
    1119779-2022-00669
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 12, 2022
    Report Date
    July 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    03829044415010
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS TO CANCEL THE ORIGINAL MFR# AS NEW INFORMATION HAS CHANGED THE REPORTABILITY OF THIS COMPLAINT TO NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYNAPSYS¿ EXTENDED PROTOCOLS TO 48H INCUBATION. THIS IS A SINGLE OCCURRENCE. THE UCA IS NOT FUNCTIONAL FOR THEIR PROTOCOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITUATION ON ARRIVAL / CURRENT SITUATION: CUSTOMERS REQUESTED TO HAVE UCA PROTOCOLS EXPANDED FOR 2 DAY INCUBATION AS THEIR SOPS REQUIRE THEM TO INCUBATE FOR 48H. WITHOUT THIS EXPANSION, THE UCA IS USELESS TO THEM. CUSTOMER OPERATES ACCORDING TO MIQ 02, A RECOMMENDED STANDARD FOR GSA SITES. ISSUE DESCRIPTION: ALL APPLICATIONS LOST THEIR CONNECTION TO INTERBASE. ERROR MESSAGE/CODE: N/A. FREQUENCY OF ISSUE: N/A. ATTEMPTED CORRECTIVE ACTION BY CUSTOMER: N/A. WORKAROUND POSSIBLE: NO. SYSTEM HISTORY (SOFTWARE/MECHANICAL CHANGES/ENVIRONMENT CUSTOMER): UCA IN GA WAS ANY OF THE PATIENT SAMPLES OR TEST RESULTS AFFECTED IN ANY WAY BY THIS PROBLEM? NO. (B)(6): (B)(6) 2022 08:51:17 (GMT), CUSTOMERS REQUESTED TO HAVE UCA PROTOCOLS EXPANDED FOR 2 DAY INCUBATION AS THEIR SOPS REQUIRE THEM TO INCUBATE FOR 48H. WITHOUT THIS EXPANSION, THE UCA IS USELESS TO THEM. CUSTOMER OPERATES ACCORDING TO MIQ 02, A RECOMMENDED STANDARD FOR GSA SITES. CURRENT SETUP FOR UCA IS: 20H INCUBATION PROGRAM FOR UCA IS USED. ADDITIONALLY THERE IS ANOTHER INCUBATION AND IMAGING STEP, WHICH TAKES PLACE AFTER THE FINAL PICTURE FOR UCA IS TAKEN. FOR THE IMAGE AFTER 48H, UCA CAN'T BE USED, SAMPLES HAVE TO BE READ ONE BY ONE, WHICH THEN ERADICATES THE BENEFIT OF THE APP ALTOGETHER. FOR A BATCH WORKLIST E.G. WITH NO GROWTH ALSO MESSAGING HAS TO BE ADJUSTED, AS THEIR LIS HAS TWO WORKLISTS (ONE FOR DAY 1 AND ONE FOR DAY 2). IF WE WERE TO MARK THE SAMPLES WITH A FINAL RESULT AFTER 24H INCUBATION, THE SAMPLE WOULD NOT SHOW UP IN THEIR WORKLISTS, IF WE WERE TO LEAVE THEM PENDING, THEY WILL NEED TO REVIEW EVERY SAMPLE INDIVIDUALLY AGAIN, WHICH ERADICATES THE BENEFIT OF THE APP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYNAPSYS¿ EXTENDED PROTOCOLS TO 48H INCUBATION. THIS IS A SINGLE OCCURRENCE. THE UCA IS NOT FUNCTIONAL FOR THEIR PROTOCOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITUATION ON ARRIVAL / CURRENT SITUATION: CUSTOMERS REQUESTED TO HAVE UCA PROTOCOLS EXPANDED FOR 2 DAY INCUBATION AS THEIR SOPS REQUIRE THEM TO INCUBATE FOR 48H. WITHOUT THIS EXPANSION, THE UCA IS USELESS TO THEM. CUSTOMER OPERATES ACCORDING TO MIQ 02, A RECOMMENDED STANDARD FOR GSA SITES. 2.ISSUE DESCRIPTION: ALL APPLICATIONS LOST THEIR CONNECTION TO INTERBASE. 3.ERROR MESSAGE/CODE: N/A. 4.FREQUENCY OF ISSUE: N/A. 5.ATTEMPTED CORRECTIVE ACTION BY CUSTOMER: N/A. 6.WORKAROUND POSSIBLE: NO. 7.SYSTEM HISTORY (SOFTWARE/MECHANICAL CHANGES/ENVIRONMENT CUSTOMER): UCA IN GA 9.WAS ANY OF THE PATIENT SAMPLES OR TEST RESULTS AFFECTED IN ANY WAY BY THIS PROBLEM? NO. (B)(6) : 2022-04-13 08:51:17 (GMT) CUSTOMERS REQUESTED TO HAVE UCA PROTOCOLS EXPANDED FOR 2 DAY INCUBATION AS THEIR SOPS REQUIRE THEM TO INCUBATE FOR 48H. WITHOUT THIS EXPANSION, THE UCA IS USELESS TO THEM. CUSTOMER OPERATES ACCORDING TO MIQ 02, A RECOMMENDED STANDARD FOR GSA SITES. CURRENT SETUP FOR UCA IS: 1. 20H INCUBATION PROGRAM FOR UCA IS USED 2. ADDITIONALLY THERE IS ANOTHER INCUBATION AND IMAGING STEP, WHICH TAKES PLACE AFTER THE FINAL PICTURE FOR UCA IS TAKEN. FOR THE IMAGE AFTER 48H, UCA CAN'T BE USED, SAMPLES HAVE TO BE READ ONE BY ONE, WHICH THEN ERADICATES THE BENEFIT OF THE APP ALTOGETHER. FOR A BATCH WORKLIST E.G. WITH NO GROWTH ALSO MESSAGING HAS TO BE ADJUSTED, AS THEIR LIS HAS TWO WORKLISTS (ONE FOR DAY 1 AND ONE FOR DAY 2). IF WE WERE TO MARK THE SAMPLES WITH A FINAL RESULT AFTER 24H INCUBATION, THE SAMPLE WOULD NOT SHOW UP IN THEIR WORKLISTS, IF WE WERE TO LEAVE THEM PENDING, THEY WILL NEED TO REVIEW EVERY SAMPLE INDIVIDUALLY AGAIN, WHICH ERADICATES THE BENEFIT OF THE APP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186118 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS) 03829044415010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown