BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243948 · Received November 25, 2008

    Report

    Report Number
    2939301-2008-03261
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 24, 2008
    Report Date
    November 15, 2008
    Manufacturer
    LIFESCAN, INC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER HAS AN UNK ERROR MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PATIENT TO OBTAIN/VERIFY ADDITIONAL INFO. THE PATIENT TESTS HIS BLOOD GLUCOSE FIVE TIMES DAILY AND MANAGES HIS DIABETES WITH SLIDING SCALE INSULIN ( 4 SHOTS OF HUMALOG TAKEN WITH MEALS) THAT IS TAKEN BASED ON METER RESULTS AND LANTUS BEFORE GOING TO BED AT NIGHT. ACCORDING TO THE PATIENT, HE CLAIMED THAT HIS METER HAD AN 'INTERMITTENT ERROR 7 MESSAGE" (ULTRA METER GOES UP TO ONLY ERROR 5) FOR THE PAST FEW WEEKS (AROUND TWELVE DAYS PRIOR). THE PATIENT STATED THAT WHEN THE METER HAD AN ERROR MESSAGE, HE WOULD USE "LIKE 30 TEST STRIPS" BEFORE GETTING A READING. ON ONE OCCASION (AT AROUND 12:00 PM) WHEN THE PATIENT REPORTEDLY GAVE UP ON TESTING DUE TO THE ALLEGED ISSUE, HE CLAIMED THAT HE DEVELOPED SYMPTOMS OF "DISORIENTED, INCOHERENT, COULD NOT WALK AND SHAKINESS THAT DEVELOPED INTO LIKE-A-SEIZURE" SOMETIME AFTER THE ISSUE. AFTER THE METER STOPPED WORKING, HE STATED THAT HE DID NOT KNOW HOW MUCH INSULIN TO TAKE AFTER HAVING LUNCH, SO HE LOOK HIS USUAL DOES OF HUMALOG). HE STATED THAT HE WAS TOO DAZED THAT HE DOES NOT REMEMBER HOW MUCH TIME PASSED BEFORE EXPERIENCING THOSE SYMPTOMS. THE PATIENT STATED THAT A ROOMMATE TOOK HIM TO THE EMERGENCY ROOM (ER) THE DAY PRIOR TO ORIGINAL DATE AT AROUND 3:00 PM. HE DOES NOT "KNOW" WHAT HIS BLOOD GLUCOSE WAS WHEN ADMITTED TO THE ER; HOWEVER, HE WAS REPORTEDLY GIVEN IV GLUCOSE AND FLUIDS. THE PATIENT'S BLOOD GLUCOSE WAS BROUGHT UP TO ABOUT 200 MG/DL BEFORE BEING RELEASED FROM THE HOSPITAL ABOUT FOUR HOURS LATER. THE ALLEGED METER ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT WAS REPORTEDLY TREATED AT THE ER FOR HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC NA 2785799

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R