BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243811 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03225
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 17, 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 (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/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA METER IS GIVING INACCURATE LOW READINGS. THIS COMPLAINT IS BEING CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE, AS THE PT WAS NOT AVAILABLE FOR FOLLOW-UP QUESTIONS. ACCORDING TO THE PT, THE INACCURATE ISSUE FIRST OCCURRED TWO MOS AGO PRIOR TO CONTACTING LFS. FOUR DAYS EARLIER, THE PT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "HEADACHE" PRIOR TO OBTAINING A BLOOD GLUCOSE READING OF "130 MG/DL" AT 8AM. THE PT REPORTEDLY TOOK LESS FOOD/DRINK AS A RESULT OF THE READING OBTAINED ON THE SUBJECT METER. AT AROUND 10 AM TO 10:30AM, THE PT OBTAINED A BLOOD GLUCOSE READING OF "195 MG/DL" ON EMERGENCY MEDICAL SERVICE METER. UPON ARRIVAL AT THE ER, THE PT REPORTEDLY RECEIVED INSULIN TREATMENT (UNSPECIFIED DOSE AND TYPE) BY A HEALTHCARE PROVIDER. 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/REPORTED SYMPTOMS SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S DIAGNOSE AND TREATMENT IN THE HOSP, WHY SHE WAS TREATED WITH INSULIN, THE DURATION OF HER HOSP STAY, AND HER BLOOD GLUCOSE READINGS DURING HER HOSP STAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE RECEIVED TREATMENT THAT CAN BE SUGGESTIVE FOR HYPERGLYCEMIA AFTER THE INACCURATE ISSUE BEGAN TWO MOS AGO. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2829235

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R