BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 3220535 · Received July 11, 2013

    Report

    Report Number
    3008382007-2013-19455
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 3, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) 2013 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH DELICA LANCING DEVICE DID NOT FIRE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED (B)(6) 2013 AT NOON. THE REPORTER STATED THE PATIENT USES DIET AND EXERCISE TO MANAGE HIS DIABETES. THE REPORTER STATED THE PATIENT NORMALLY TESTS TWICE A DAY. THE REPORTER STATED THE PATIENT MADE NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER STATED A FEW MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIZZINESS AND SHAKINESS.¿ THE REPORTER STATED THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2013 AND WAS TREATED WITH AN UNKNOWN INJECTION. THE REPORTER STATED THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED BUT SHE WAS UNABLE TO RECALL THE READING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT AND THE PATIENT WAS USING THE CORRECT LANCETS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319547 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R