BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081782 · Received July 23, 2008

    Report

    Report Number
    2939301-2008-01489
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 17, 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE DAY BEFORE, AT 8:30 PM. HOWEVER, THE PT ALSO CLAIMED THAT SHE HAS HAD TO REPLACE THE METER'S BATTERY EVERY 4 MONTHS. AS A RESULT OF THE ALLEGED METER ISSUE, THE PT CLAIMED SHE TOOK AN INCREASED DOSE OF DIABETES MEDICATION. THE PT TOOK 10 UNITS OF NOVOLOG INSULIN ON AN UNSPECIFIED DATE/TIME. AFTER THE REPORTED METER ISSUE BEGAN, THE PT ALSO CLAIMED THAT SHE DEVELOPED SYMPTOMS OF BLURRY VISION AND NAUSEA. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PT'S TESTING FREQUENCY, HER DIABETES MANAGEMENT AND MEDICATION REGIMENS, WHAT DATE/TIME THE SYMPTOMS DEVELOPED, AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS STARTED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DATE/TIME THE PT INCREASED HER INSULIN DOSAGE, IF THE PT ATTRIBUTED THE REPORTED SYMPTOMS TO HIGH/LOW BLOOD GLUCOSE, AND WHAT HER LAST BLOOD GLUCOSE READING WAS BEFORE THE REPORTED ISSUE BEGAN. THE ALLEGED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 1022684

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening