BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1081637 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01465
    Event Type
    Injury
    Date Received
    July 22, 2008
    Report Date
    July 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    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 METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 14, 2008, A PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRASMART METER WOULD NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT NORMALLY TESTS HIS BLOOD GLUCOSE 6-8 TIMES A DAY AND MANAGES HIS DIABETES WITH 29 UNITS OF LANTUS AND HUMALOG TAKEN ON A SLIDING SCALE. ABOUT TWO AND HALF WEEKS PRIOR TO CONTACTING LFS, THE PATIENT REPORTEDLY DROPPED THE METER INTO THE WATER, AND THEN THE METER ALLEGEDLY WOULD NOT POWER ON (USE ERROR). AS A RESULT OF THE REPORTED INCIDENT, THE PATIENT STATED THAT HE CONTINUED TAKING THE USUAL DOSE OF LANTUS AND ADJUSTED HIS INSULIN BASED ON HIS FEELINGS. APPROXIMATELY A DAY AFTER THE ALLEGED INCIDENT, THE PATIENT MENTIONED THAT HE DEVELOPED SYMPTOMS OF "FREQUENT URINATION AND THIRST" AND REPORTEDLY SOUGHT MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP). BECAUSE THE SUBJECT METER WOULD NOT TURN ON, THE PATIENT REPORTEDLY PURCHASED ANOTHER METER "ACCUCHECK" TO TEST HIS BLOOD SUGAR AT THE HCP'S CLINIC; A REPORTED BLOOD GLUCOSE READING OF "OVER 400 MG/DL" WAS OBTAINED. THERE WAS NO TREATMENT MENTIONED WHILE HE WAS AT THE CLINIC. THE PATIENT MENTIONED TO THE MAS THAT HE PERFORMED SELF-TREATMENT BY INCREASING HIS HUMALOG (UNSPECIFIED AMOUNT) AT AN UNSPECIFIED TIME AND REPORTEDLY FELT WELL WITHIN A FEW HOURS WITH A REPORTED BLOOD GLUCOSE OF "150 MG/DL" TAKEN ON THE ACCUCHECK METER. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R