BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 335715 · Received May 30, 2001

    Report

    Report Number
    2939301-2001-00481
    Event Type
    Injury
    Date Received
    May 30, 2001
    Date of Event
    April 14, 2001
    Report Date
    May 1, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING PAIN IN BOTH FOREARMS 2 WEEKS AFTER USING A ONE TOUCH ULTRASOFT ADJUSTABLE BLOOD SAMPLER FOR ALTERNATE SITE TESTING. ON THE DAY OF THE EVENT, PT WOKE UP WITH PAIN ON BOTH FOREARMS. ABOUT 2 WEEKS LATER, PT SAW PHYSICIAN AFTER PAIN DID NOT SUBSIDE FOR 2 WEEKS. PHYSICIAN TREATED PT WITH THE ANTI-FUNGAL DRUGS, CLOTRIMADERM CREAM AND TERBINAFINE TAB 250MG QD FOR THREE MONTHS FOR AN UNKNOWN DIAGNOSIS. AS OF THE NEXT MONTH, THE TERBINAFINE TAB DOSE HAS BEEN INCREASED TO 375MG QD FOR DIFFICULTY IN BREATHING. PT HAS BEEN USING ACETYL SALICYLIC ACID AS A BLOOD THINNER FOR AN UNKNOWN CONDITION. BLOOD THINNERS COULD LEAD TO ABNORMAL BLEEDING. LATER THAT MONTH, PT WAS STARTED ON THE ANTIBIOTIC RETAMICIN FOR A SYSTEMIC UNKNOWN INFECTION. PT HAS ALSO BEEN EXPERIENCING BILATERAL LOWER LIMB SWELLING OF UNKNOWN CAUSE. FROM THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT A DEVICE-RELATED SERIOUS INJURY DID OCCUR. SHOULD NO FURTHER INFORMATION BECOME AVAILABLE, LIFESCAN INC. WILL CONSIDER THE MATTER CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24978 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention RETAMICIN.| ACETYL SALICYLIC ACID, TERBINAFINE, CLOTRIMADERM,