BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRASMART METER

    MDR report key: 1243817 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03217
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRASMART METER WAS PROMPTING A BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE REPORTER WAS UNABLE TO BE REACHED BY PHONE TO ANSWER ADDITIONAL FOLLOW-UP QUESTIONS INQUIRED BY THE MEDICAL AFFAIRS SPECIALIST (MAS). THE PATIENT'S MOTHER REPORTED THAT A WEEK PRIOR TO CONTACTING LFS, SHE HAD REPLACED THE BATTERIES OF THE SUBJECT METER, AND ON THE AFTERNOON OF AN UNSPECIFIED DATE, THE BATTERY INDICATOR MESSAGE BEGAN TO APPEAR AGAIN. THE REPORTER STATED THAT ON THE AFTERNOON OF 2008, THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE AS A RESULT OF THE ISSUE. APPROXIMATELY TWO HOURS AFTER ATTEMPTING TO TEST, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF A "HIGH BLOOD SUGAR" AND TREATED HIMSELF WITH 5 UNITS OF NOVO RAPID INSULIN. THE REPORTER INFORMED THE CSR THAT THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENT); HOWEVER, IT IS UNCLEAR WHAT ACTION, IF ANY, THE PATIENT TOOK AT THE TIME THE SUBJECT METER BEGAN TO PROMPT THE BATTERY INDICATOR MESSAGE. IT IS ALSO UNKNOWN WHEN THE PATIENT WAS LAST ABLE TO TEST WITH THE METER SUCCESSFULLY PRIOR TO THIS EVENT. AT THE TIME OF TROUBLESHOOTING, THE CSR DISCOVERED THAT THERE WAS TRAUMA TO THE SUBJECT METER. THE REPORTER STATED THAT THERE WAS "ACCIDENTAL WATER DAMAGE." REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED "HIGH BLOOD SUGAR" SYMPTOMS AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2855554

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R