BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENLET LANCING DEVICE

    MDR report key: 1020933 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00392
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    March 6, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN THAT A LANCING DEVICE ISSUE WITH HER PENLET II LANCING DEVICE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PATIENT BY PHONE TO OBTAIN ADDITIONAL INFORMATION SINCE A PHONE NUMBER WAS NOT PROVIDED. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE CUSTOMER CARE ADVOCATE'S DOCUMENTATION. THE PATIENT STATED THAT THE RELEASE BUTTON WAS BROKEN AND WHEN SHE ATTEMPTED TO FIX IT "MAYBE 4-5 DAYS AGO," THE LANCING DEVICE FELL APART. SHE SKIPPED 2 UNITS OF HUMULIN R AND 10 UNITS OF HUMULIN N AS A RESULT OF THE LANCING DEVICE ISSUE. AT AN UNSPECIFIED TIME, SHE REPORTEDLY FELT SICK TO HER STOMACH, FELT WEAK, HAD DIFFICULTIES EATING AND WAS SLEEPING A LOT AFTER THE LANCING DEVICE ISSUE BEGAN. IT IS UNCLEAR IF HER SYMPTOMS OCCURRED BEFORE OR AFTER SHE SKIPPED HER MEDICATIONS. THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION. THE CUSTOMER CARE ADVOCATE (CCA) WENT THROUGH TROUBLESHOOTING WITH THE PATIENT AND NOTED THAT THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT WOULD HAVE BEEN HELPFUL TO KNOW HOW OFTEN THE PATIENT USUALLY TESTS ON HER METER AND WHAT DIABETES MEDICATION REGIMEN IS. IT WOULD ALSO BE HELPFUL TO KNOW IF THE PATIENT HAD ANY BACKUP DEVICES TO TEST WITH, WHEN SHE SKIPPED HER MEDICATIONS, AND WHEN SHE DEVELOPED HER SYMPTOMS. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS AFTER HER LANCING DEVICE FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENLET LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA 2753277

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening