BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD INSULIN SYRINGE

    MDR report key: 8489877 · Received April 7, 2019

    Report

    Report Number
    2243072-2019-00668
    Event Type
    Malfunction
    Date Received
    April 7, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 22, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNKNOWN BD INSULIN SYRINGE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. IT WAS REPORTED CUSTOMER TOOK TOO MUCH OF A BOLUS DUE TO THE LARGER SIZE OF THE SYRINGE BODY AND NOT BEING ABLE TO DETERMINE AN ACCURATE INSULIN AMOUNT BASED ON THE SYRINGE BODY SIZE. THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. A. ISSUE: CUSTOMER REPORTS BG THIS MORNING. NOTE THAT CUSTOMER WAS NOT USING THE PUMP AT THE TIME SINCE SHE HAD JUST RECEIVED THE REPLACEMENT PUMP AND HAD NOT SET IT UP YET. B. DATE: (B)(6) 2019. C. WHAT BG LEVEL WAS REPORTED? 36MG/DL. D. WHAT IS THE SUSPECTED CAUSE OF THE LOW BG? CUSTOMER STATES SHE TOOK A SYRINGE BOLUS WITH THE TANDEM-PROVIDED SYRINGE AND NEEDLE THAT ARE USED TO LOAD THE CARTRIDGE. SHE STATED SHE PROBABLY TOOK TOO MUCH OF A BOLUS DUE TO THE LARGER SIZE OF THE SYRINGE BODY AND NOT BEING ABLE TO DETERMINE AN ACCURATE INSULIN AMOUNT BASED ON THE SYRINGE BODY SIZE. SHE SAID THEREFORE THE LOW WAS USER ERROR. CUSTOMER RE-ITERATED SHE WAS NOT USING THE PUMP AT TIME OF THE LOW. E. IF BG < 54 AND CAUSE IS UNKNOWN, CAN CUSTOMER UPLOAD PUMP TO T:CONNECT? N/A. F. HOW WAS THE LOW BG TREATED? SUGAR DRINKS. G. DID CUSTOMER REQUIRE ASSISTANCE FROM 3RD PARTY? IF YES, WHO WAS 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. H. DID EVENT CAUSE ANY INJURY? IF YES, DEFINE INJURY. NO. I. WAS CUSTOMER INSTRUCTED TO CALL BACK TO TROUBLESHOOT WHEN HE/SHE EXPERIENCES A CURRENT LOW BG & TO CONSULT HIS/HER HCP? YES. CTS ALSO ADVISED NOT TO USE THE TANDEM-PROVIDED NEEDLE AND SYRINGE FOR A BOLUS. J. IF CAUSE OF LOW BG IS UNKNOWN, IS CARTRIDGE AVAILABLE FOR RETURN? N/A. K. OBTAIN CARTRIDGE LOT #: N/A. L. IF CUSTOMER IS USING THE T:SLIM X2, DID THEY HAVE BASAL IQ FEATURE TURNED ON AT TIME OF EVENT? N/A.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNKNOWN BD INSULIN SYRINGE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. IT WAS REPORTED CUSTOMER TOOK TOO MUCH OF A BOLUS DUE TO THE LARGER SIZE OF THE SYRINGE BODY AND NOT BEING ABLE TO DETERMINE AN ACCURATE INSULIN AMOUNT BASED ON THE SYRINGE BODY SIZE. THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. ISSUE: CUSTOMER REPORTS BG THIS MORNING. NOTE THAT CUSTOMER WAS NOT USING THE PUMP AT THE TIME SINCE SHE HAD JUST RECEIVED THE REPLACEMENT PUMP AND HAD NOT SET IT UP YET. DATE: (B)(6) 2019. WHAT BG LEVEL WAS REPORTED? 36MG/DL. WHAT IS THE SUSPECTED CAUSE OF THE LOW BG? CUSTOMER STATES SHE TOOK A SYRINGE BOLUS WITH THE TANDEM-PROVIDED SYRINGE AND NEEDLE THAT ARE USED TO LOAD THE CARTRIDGE. SHE STATED SHE PROBABLY TOOK TOO MUCH OF A BOLUS DUE TO THE LARGER SIZE OF THE SYRINGE BODY AND NOT BEING ABLE TO DETERMINE AN ACCURATE INSULIN AMOUNT BASED ON THE SYRINGE BODY SIZE. SHE SAID THEREFORE THE LOW WAS USER ERROR. CUSTOMER RE-ITERATED SHE WAS NOT USING THE PUMP AT TIME OF THE LOW. HOW WAS THE LOW BG TREATED? SUGAR DRINKS. DID CUSTOMER REQUIRE ASSISTANCE FROM 3RD PARTY? IF YES, WHO WAS 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. DID EVENT CAUSE ANY INJURY? IF YES, DEFINE INJURY. NO WAS CUSTOMER INSTRUCTED TO CALL BACK TO TROUBLESHOOT WHEN HE/SHE EXPERIENCES A CURRENT LOW BG & TO CONSULT HIS/HER HCP? YES. CTS ALSO ADVISED NOT TO USE THE TANDEM-PROVIDED NEEDLE AND SYRINGE FOR A BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282939 UNKNOWN BD INSULIN SYRINGE INSUIN SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other