BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1181631 · Received September 29, 2008

    Report

    Report Number
    2939301-2008-02446
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCT FOR EVAL, BUT HAS NOT YET REC'D IT. IF THE PROD 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/PT CALLED LIFESCAN (LFS) IN 2008, AND ALLEGED THAT A ONETOUCH ULTRA METER WAS POWERING OFF DURING USE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT THE F/U QUESTION TO THE CUSTOMER SVC AGENT (CSA) TO ASK THE PT AND VERIFIED THE FOLLOWING INFO. THE CSA DISCOVERED THAT THE PT DID NOT REPLACE THE BATTERY IN THE METER AS PER THE OWNER'S MANUAL. THE CSA ALSO VERIFIED THAT THERE WAS NO MISUSE OF THE PROD AND THAT THE PT HAD NOT ATTEMPTED TO DOWNLOAD THE METER PRIOR TO THE ALLEGED ISSUES. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THE PT INDICATED THAT THE REPORTED ISSUE STARTED ABOUT 15 DAYS BEFORE HE CALLED LFS. HE CONTINUED TO TEST HIS BLOOD SUGAR ON THE METER AFTER THE ALLEGED ISSUE STARTED AND WAS ABLE TO TEST HIS BLOOD SUGAR INTERMITTENTLY. THE PT'S PREVIOUS READINGS WERE NOT KNOWN. ON THE DAY BEFORE AROUND 9:30 PM, THE PT REPORTEDLY FELT "EXCESSIVE SWEATINESS AND FAINTNESS". A FRIEND ARRIVED TO HELP HIM AND THE PT ATE SOME SUGAR AND FOOD AND FELT BETTER IN ABOUT AN HR. THE PT MENTIONED THAT HE WAS UNABLE TO TEST HIS BLOOD SUGAR THAT DAY PRIOR TO EXPERIENCING ALLEGED SYMPTOMS. THE PT HAD A NORMAL AMOUNT OF DINNER AT AROUND 8:30 PM THAT DAY. HE HAD TAKEN 9 UNITS OF NOVORAPID INSULIN AND 14 UNITS OF LANTUS THAT EVENING AROUND 9:15 PM. HE DENIED RECEIVING ANY MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. HE WAS NOT TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. THE PT INDICATED THAT IF HE REC'D A LOWER BLOOD SUGAR READING PRIOR TO DINNER THAT NIGHT, HE PROBABLY WOULD HAVE BEEN ABLE TO MAKE A CHANGE IN HIS INSULIN REGIMEN IN ORDER TO AVOID DEVELOPING "HYPOGLYCEMIC" SYMPTOMS. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT WAS ALLEGEDLY UNABLE TO TEST HIS BLOOD SUGAR DUE TO THE REPORTED ISSUE. HE THEN REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND FELT BETTER AFTER ADMINISTERING SELF-TREATMENT. DIABETES CARE MGMT: THE PT TESTS HIS BLOOD SUGAR 4 TO 5 TIMES DAILY. THE PT TAKES NOVORAPID INSULIN MORNING, NOON AND EVENING BASED ON A SLIDING SCALE AND ALSO TAKES 14 UNITS OF LANTUS EVERY EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2845247

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R