BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1394061 · Received May 21, 2009

    Report

    Report Number
    2939301-2009-02861
    Event Type
    Injury
    Date Received
    May 21, 2009
    Report Date
    May 4, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 2009, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA2 METER IS GIVING INACCURATE CONTROL HIGH. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. A NO RESPONSE LETTER WAS SENT TO THE PT. THE INACCURATE CONTROL HIGH ISSUE BEGAN THE DAY BEFORE AT 7 AM. THE PT CLAIMED THAT THE ONE TOUCH ULTRA2 METER IS GIVING CONTROL SOLUTION READINGS OF "155, 161, 117, 168, 119, 179, 130, 195, 124, 118, AND 142 MG/DL", WHICH IS NOT WITHIN THE CONTROL SOLUTION RANGE OF "86-115 MG/DL". AS A RESULT OF THE REPORTED ISSUE, THE PT REPORTEDLY INCREASED HIS JANUMET DIABETES MEDICATION. IT IS NOT KNOWN IF THE PT WAS ABLE TO OBTAIN ANY BLOOD GLUCOSE READINGS ON THE SUBJECT METER, THEREAFTER. AT 11 AND HALF HOURS LATER, THE PT REPORTEDLY DEVELOPED SYMPTOM DESCRIBED AS "FELT A LITTLE SHAKY". THE PT DID NOT RECEIVE ANY MEDICAL INTERVENTION AND DID NOT TEST ON ANOTHER METER. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, THE DURATION OF THE SYMPTOMS, WHAT TREATMENT DID THE PT RECEIVE IN ORDER FOR THE SYMPTOMS TO ABATE, COULD THE SYMPTOMS HAVE BEEN PREVENTED, WAS THE PT'S DIABETES MEDICATION CHANGED IMMEDIATELY BEFORE OR SOMETIME AFTER THE AFOREMENTIONED SYMPTOMS, AND THE EVENTS LEADING UP TO THE PT'S MEDICAL INTERVENTION, SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED, BECAUSE THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA, AFTER THE CONTROL SOLUTION ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2897700

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening