BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 5093772 · Received September 22, 2015

    Report

    Report Number
    2939301-2015-40140
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 18, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HER ONETOUCH DELICA LANCING DEVICE DID NOT FULLY PENETRATE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON THE MORNING OF (B)(6) 2015 (TIME NOT PROVIDED). THE PATIENT MANAGES HER DIABETES WITH SELF-ADJUSTING INSULIN. THE PATIENT STATED THAT SHE TOOK HER USUAL DOSE OF METFORMIN MEDICATION (1 G IN THE MORNING AND 500 MG AT NIGHT) ON (B)(6) 2015 IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOMS OF "HEADACHE, WEAK, DIZZY, SHAKY AND LIGHT HEADED) AFTER THE ALLEGED PRODUCT ISSUE BEGAN (DATE/TIME UNKNOWN); HOWEVER THE PATIENT DENIED THAT SHE HAD RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE CORRECT LANCETS WERE BEING USED (33G), THERE WAS NO INDICATION OF PRODUCT MISUSE, THE PATIENT WAS USING THE CORRECT SAMPLE COLLECTION TECHNIQUE AND THE SUBJECT LANCING DEVICE WAS NOT BEING USED FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED THE SYMPTOM OF "SHAKY" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THIS SYMPTOM DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626733 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening