BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1092303 · Received August 1, 2008

    Report

    Report Number
    2939301-2008-01649
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN ON (B)(6)2008 AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PT REPORTED THAT THE ALLEGED ISSUE FIRST BEGAN IN THE MORNING OF (B)(6) 2008. SHE REPORTED OBTAINING A RESULT OF 165 MG/DL ON THE SUBJECT METER. THE PT ALSO MENTIONED THAT AFTER THE REPORTED ISSUE BEGAN, SHE EXPERIENCED BEING ANXIOUS, AND SHAKY. HOWEVER, SHE REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION. THE PT WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). HOWEVER, IT WAS DISCOVERED THAT THE METER WAS NOT CODED CORRECTLY TO MATCH THE CODE ON THE TEST STRIP VIAL (USE ERROR). THE PT WAS WALKED THROUGH SETTING UP THE CORRECT CODE AND A CONTROL SOLUTION TEST WAS PERFORMED, WHICH PASSED WITHIN RANGE. A BLOOD TEST WAS ALSO PERFORMED WITH A RESULT OF 105 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED THAT SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE REPORTEDLY DID NOT RECEIVE ANY MEDICAL ATTENTION. THE METER/STRIPS WERE WITHIN SPECIFICATION WITH THE CONTROL SOLUTION TEST AFTER THE CORRECT CODE WAS SET IN THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/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 2835000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening