BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1051864 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00847
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THEY DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) ON APRIL 28, 2008 ON BEHALF OF THE LAY USER/PATIENT AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS GIVING HER "ERROR 2" MESSAGES. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE REPORTER ON APRIL 9, 2008 AND VERIFIED THE FOLLOWING INFORMATION. ACCORDING TO THE PATIENT'S SON, THE REPORTED ISSUE STARTED ABOUT A MONTH BEFORE HE CALLED LFS. THE PATIENT WAS UNABLE TO TEST HER BLOOD SUGAR DURING THE ISSUE. PRIOR TO THE REPORTED ISSUE, THE PATIENT WAS TESTING HER BLOOD SUGAR ONCE EVERY NIGHT BEFORE BEDTIME AND WAS TAKING LANTUS 28 UNITS TWICE DAILY. ON TEN DAYS PRIOR TO ORIGINAL DATE AT AROUND 9:30 AM TO 10:00 AM, THE PATIENT WAS NOT FEELING WELL. THE REPORTER WAS UNABLE TO PROVIDE INFORMATION ON SPECIFIC SYMPTOMS. THE PATIENT'S SON TOOK HER TO THE EMERGENCY ROOM. HER BLOOD SUGAR WAS TESTED AT THE EMERGENCY ROOM AND HAD RECEIVED A HIGH BLOOD SUGAR READING. THE REPORTER WAS UNABLE TO RECALL THE READING RECEIVED AT THE EMERGENCY ROOM. SHE WAS TREATED WITH UNKNOWN INSULIN. SHE WAS HOSPITALIZED FOR ABOUT A WEEK, AS SHE WAS ALSO DIAGNOSED WITH HIGH BLOOD PRESSURE AND RENAL PROBLEMS. THE REPORTER ALSO MENTIONED THAT THE PATIENT WAS TAKING 28 UNITS OF LANTUS TWICE DAILY PRIOR TO THE HOSPITALIZATION. DURING THE HOSPITALIZATION, THE DOCTOR DECREASED HER DOSAGE OF LANTUS TO 23 UNITS TWICE DAILY AND SHE WAS ALSO ADVISED TO TEST BLOOD SUGAR TWICE DAILY. THE REPORTER STATED THAT THE PATIENT COULD HAVE PROBABLY AVOIDED BEING HYPERGLYCEMIC, IF SHE COULD HAVE TESTED HER BLOOD SUGAR REGULARLY. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PATIENT WAS USING CORRECT TECHNIQUE TO TEST. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS THE REPORTER ALLEGED THE PATIENT WAS UNABLE TO TEST HER BLOOD SUGAR DUE TO THE REPORTED ISSUE AND WAS LATER TREATED WITH INSULIN IN THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2551571

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R