BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 779878 · Received November 8, 2006

    Report

    Report Number
    2939301-2006-01544
    Event Type
    Injury
    Date Received
    November 8, 2006
    Date of Event
    September 27, 2006
    Report Date
    October 25, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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

    ON OCTOBER 25, 2006 THE LAY PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA METER HAD A CRACKED CASE AND SHE WAS NOT ABLE TO TEST WITH THE METER. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT A LETTER TO THE PATIENT BECAUSE SHE COULD NOT BE REACHED BY PHONE ON TWO DIFFERENT DAYS. THE MAS LISTENED TO THE RECORDED CALL TO LFS TO OBTAIN ADDITIONAL INFORMATION INCLUDED BELOW: THE PATIENT SAID SHE OBTAINED THE METER IN JULY 2006 AND "IT GOT A CRACK." SHE DID NOT KNOW HOW THE METER BECAME CRACKED, BUT SHE CLAIMS THE METER STOPPED WORKING ON SEPTEMBER 25, 2006. THE PATIENT SAID SHE "DIDN'T KNOW WHAT TO TAKE" BECAUSE SHE "DIDN'T KNOW WHAT HER BLOOD SUGAR WAS." NO SPECIFIC INFORMATION REGARDING THE PATIENT'S DIABETES TREATMENT REGIMEN WAS PROVIDED. SHE WENT TO THE ER BECAUSE SHE WAS DIZZY AND HAD PAIN IN HER FEET. A RESULT OF "290 SOMETHING" WAS OBTAINED ON THE HOSPITAL METER. THE PATIENT WAS TREATED WITH PAIN MEDICATION FOR NEUROPATHY AND INSULIN; THE INSULIN TYPE AND DOSE WERE NOT PROVIDED. THE PATIENT WAS APPARENTLY ADMITTED TO THE HOSPITAL BECAUSE SHE TOLD THE LFS CUSTOMER CARE ADVOCATE (CCA) SHE HAD JUST BEEN RELEASED FROM THE HOSPITAL WHEN SHE CALLED LFS ON OCTOBER 25, 2006. HOWEVER, THE SPECIFIC HOSPITALIZATION DATES AND DIAGNOSIS WERE NOT PROVIDED. THE PATIENT TOLD THE CCA SHE LEFT THE REPORTED METER AT THE HOSPITAL BECAUSE IT DIDN'T WORK. THEREFORE, THE CCA WAS UNABLE TO COMPLETE TROUBLESHOOTING THE METER. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT WAS UNABLE TO OBTAIN A READING ON THE LFS PRODUCT. SHE EXPERIENCED SYMPTOMS AND AN ELEVATED BLOOD GLUCOSE READING IN THE ER. SHE WAS TREATED WITH INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2650115

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R