BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1780057 · Received August 2, 2010

    Report

    Report Number
    2939301-2010-06164
    Event Type
    Injury
    Date Received
    August 2, 2010
    Report Date
    July 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    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

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRASMART METER IS GIVING INACCURATE HIGH READINGS IN THE 400S MG/DL COMPARED TO PAST RESULTS FROM THE ONETOUCH BASIC METER. THE PATIENT MANAGES HIS DIABETES WITH SELF ADJUSTING INSULIN. THE ALLEGED INACCURATE HIGH ISSUE BEGAN ON (B)(6) 2010. BASED ON THE HIGH RESULTS OBTAINED ON THE SUBJECT METER, THE PATIENT TOOK INSULIN BASED ON THE DOCTOR'S RECOMMENDED SLIDING SCALE. ALTHOUGH THE PATIENT TOOK LESS THAN WHAT THE SLIDING SCALE PRESCRIBED, HE DEVELOPED SYMPTOMS DESCRIBED AS "COULDN'T WALK, COLD SWEATS, AND SHAKING." IT IS NOT CLEAR WHAT TREATMENT THE PATIENT RECEIVED TO ABATE THE SYMPTOMS. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE METER TO OTHER METER COMPARISON WAS PERFORMED MORE THAN 30 MINUTES OF EACH OTHER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER HE TOOK INSULIN BASED ON THE ALLEGED LFS METER READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2985606

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening