BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1813351 · Received August 24, 2010

    Report

    Report Number
    2939301-2010-07099
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 ULTRA METER DOES NOT TURN ON. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. THE POWER ISSUE BEGAN AROUND (B)(6) 2010. THERE WAS NO ALTERATION TO THE PATIENT'S DIABETES MANAGEMENT AS A RESULT OF THE PRODUCT ISSUE. 3 DAYS LATER, THE PATIENT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "SHAKY, CLAMMY, AND SWEATS." THERE WAS NO ALLEGATION OF MEDICAL INTERVENTION FOR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA DUE TO THE POWER ISSUE. 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 POWER ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA 3 DAYS AFTER THE PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2964512

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening