BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH BASIC ENHANCED METER

    MDR report key: 1060328 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01094
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 6, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) IN 2008 ON BEHALF OF THE LAY USER/PATIENT AND ALLEGED THAT A ONE TOUCH BASIC METER WOULD NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT ON SIX DAYS LATER AND VERIFIED THE FOLLOWING INFORMATION. THE PATIENT'S SON INDICATED THAT THE REPORTED ISSUE STARTED AT THE END OF THE PREVIOUS MONTH. THE PATIENT WAS REPORTEDLY UNABLE TO TEST HER BLOOD SUGAR DURING THE ISSUE. THE PATIENT NORMALLY TESTS HER BLOOD SUGAR THREE TIMES DAILY, IN THE MORNING, AFTERNOON, AND EVENING. SHE TAKES NOVALOG INSULIN BASED ON THE METER READINGS ACCORDING TO A SLIDING SCALE. SHE WAS REPORTEDLY GUESSING THE DOSAGE OF NOVALOG INSULIN DURING THE ISSUE WHEN SHE WAS UNABLE TO TEST HER BLOOD SUGAR. SHE WAS TAKING ABOUT 8 UNITS OF NOVALOG. ON FOUR DAYS PRIOR TO ORIGINAL DATE AT AROUND 11:00 AM, SHE WAS ALLEGING FEELING SYMPTOMS OF LOW BLOOD SUGAR. THE PATIENT'S SON WAS UNABLE TO PROVIDE THE EXACT SYMPTOMS THAT SHE WAS FEELING. HE TOOK HER TO THE EMERGENCY ROOM. HER BLOOD SUGAR WAS TESTED AT THE EMERGENCY ROOM AND RECEIVED A READING OF 46 MG/DL. HE MENTIONED THAT SHE WAS TREATED WITH SOME IV FLUIDS AT THE EMERGENCY ROOM AND SHE FELT BETTER AFTER THAT. SHE WAS KEPT AT THE HOSPITAL FOR A DAY AND THEN WAS RELEASED. ON THAT DAY, PRIOR TO DEVELOPING LOW BLOOD SUGAR SYMPTOMS, THE PATIENT WAS REPORTEDLY UNABLE TO TEST HER BLOOD SUGAR AND HAD TAKEN 8 UNITS OF NOVALOG. SHE WAS EATING AS USUAL DURING THAT TIME. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PATIENT HAD REPLACED THE BATTERY IN THE METER PER THE OWNER'S MANUAL, THE CONDITION OF THE BATTERY CONTACTS WAS GOOD, THE BATTERIES WERE INSTALLED CORRECTLY AND THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PATIENT WAS UNABLE TO CALCULATE THE ACCURATE DOSAGE OF INSULIN TO ADMINISTER DUE TO THE REPORTED ISSUE AND LATER, REPORTEDLY DEVELOPED LOW BLOOD SUGAR SYMPTOMS AND RECEIVED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH BASIC ENHANCED METER GLUCOSE MONITORING SYSTEM/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R