BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA PLUS LANCING DEVICE

    MDR report key: 13405639 · Received January 31, 2022

    Report

    Report Number
    2939301-2022-03009
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    January 22, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ASAHI POLYSLIDER COMPANY LIMITED
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE LAY USER/PATIENT¿S DAUGHTER CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THE LANCET IN THE PATIENT¿S ONETOUCH DELICA PLUS LANCING DEVICE WAS NOT FULLY PENETRATING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED LANCING DEVICE ISSUE BEGAN 2 WEEKS PRIOR TO CONTACTING LFS. THE REPORTER CLAIMED THE LANCET WAS NO LONGER FULLY PENETRATING EVEN AT DEPTH SETTING 7. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (1 PILL OF GLICLAZIDE AND 1000 MG METFORMIN). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN WHEN SHE WAS UNABLE TO MEASURE HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT ON (B)(6) 2022 AT 8:00 PM, THE PATIENT BECAME ¿REALLY THIRSTY, HER TONGUE WAS REALLY SICK, SHE HAD A LOT OF FATIGUE AND SHE FELT LIKE SHE WAS SWAYING LIKE THE BOTTOM WAS FALLING OUT¿; SYMPTOMS SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE LEVEL, AFTER SEARCHING THE SYMPTOMS ONLINE. THE REPORTER CLAIMED SHE GAVE THE PATIENT WATER AND ADVICE TO DO SOME EXERCISE, AS TREATMENT FOR THE SYMPTOMS. THE REPORTER INFORMED THE CCA THAT THE PATIENT HAD LOST A LOT OF WEIGHT RECENTLY WHICH SHE STATED COULD ALSO BE A FACTOR IN THE EVENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT LANCING DEVICE HAD BEEN IN USE FOR 3 YEARS AND THAT THE CORRECT LANCETS WERE BEING USED. THE CCA REVIEWED THE PATIENT¿S TECHNIQUE ON HOW TO USE THE LANCING DEVICE AND THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER SHE WAS UNABLE TO MEASURE HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. THE SUBJECT DEVICE COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE LAY USER/PATIENT¿S DAUGHTER CONTACTED LIFESCAN (LFS) CANADA, ALLEGING THAT THE LANCET IN THE PATIENT¿S ONETOUCH DELICA PLUS LANCING DEVICE WAS NOT FULLY PENETRATING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED LANCING DEVICE ISSUE BEGAN 2 WEEKS PRIOR TO CONTACTING LFS. THE REPORTER CLAIMED THE LANCET WAS NO LONGER FULLY PENETRATING EVEN AT DEPTH SETTING 7. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (1 PILL OF GLICLAZIDE AND 1000 MG METFORMIN). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN WHEN SHE WAS UNABLE TO MEASURE HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT ON (B)(6) 2022 AT 8:00 PM, THE PATIENT BECAME ¿REALLY THIRSTY, HER TONGUE WAS REALLY SICK, SHE HAD A LOT OF FATIGUE AND SHE FELT LIKE SHE WAS SWAYING LIKE THE BOTTOM WAS FALLING OUT¿; SYMPTOMS SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE LEVEL, AFTER SEARCHING THE SYMPTOMS ONLINE. THE REPORTER CLAIMED SHE GAVE THE PATIENT WATER AND ADVICE TO DO SOME EXERCISE, AS TREATMENT FOR THE SYMPTOMS. THE REPORTER INFORMED THE CCA THAT THE PATIENT HAD LOST A LOT OF WEIGHT RECENTLY WHICH SHE STATED COULD ALSO BE A FACTOR IN THE EVENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT LANCING DEVICE HAD BEEN IN USE FOR 3 YEARS AND THAT THE CORRECT LANCETS WERE BEING USED. THE CCA REVIEWED THE PATIENT¿S TECHNIQUE ON HOW TO USE THE LANCING DEVICE AND THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER SHE WAS UNABLE TO MEASURE HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. THE SUBJECT DEVICE COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763181 OT DELICA PLUS LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK ASAHI POLYSLIDER COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Life Threatening