BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1032811 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00604
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, 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

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE. THE PT TESTS HER BLOOD GLUCOSE 4 TIMES A DAY. SHE TAKES SLIDING-SCALE NOVALOG INSULIN BASED ON HER METER READINGS AND 55 UNITS OF LANTUS INSULIN EVERY NIGHT. THE PT INDICATED THAT THE REPORTED METER ISSUE STARTED ABOUT 2 WEEKS BEFORE THE EVENT OCCURRED ON THE PREVIOUS MONTH. DURING THAT TIME, THE PT WAS GUESSING ON HER DOSAGES OF SLIDING-SCALE NOVALOG INSULIN SINCE SHE DID NOT HAVE A METER TO TEST WITH . AROUND 11:30 AM OR 12:30 PM ON THE DAY OF THE EVENT, THE PT WAS IN A HOSPITAL HAVING PHYSICAL THERAPY. DURING THE THERAPY SESSION, THE PT DEVELOPED SYMPTOMS OF SWEATING AND TREMBLING. THE PT WAS TAKEN TO THE EMERGENCY ROOM (ER) WITH HER BLOOD GLUCOSE WAS TESTED AND ON AN ER/HOSPITAL METER AND A RESULT OF "70 MG/DL" WAS OBTAINED. THE PT WAS TREATED WITH ORANGE JUICE AND CRACKERS. THE PT MENTIONED THAT SHE HAD TAKEN A GUESSED AMOUNT OF NOVALOG INSULIN EARLIER IN THE MORNING PRIOR TO ATTENDING THE PHYSICAL THERAPY SESSION. THE REPORTED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL TREATMENT IN AN ER 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 2766239

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R