BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE MONITORING SYS/KIT

    MDR report key: 1903986 · Received November 20, 2010

    Report

    Report Number
    2939301-2010-10204
    Event Type
    Injury
    Date Received
    November 20, 2010
    Report Date
    October 31, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 510K #K053529.

    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 USER'S GUIDE OF THE ONETOUCH ULTRA2 METER IS TOO BIG AND NOT USER FRIENDLY. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION OF METFORMIN AND GLIPIZIDE. THE PATIENT EXPERIENCED THE ISSUE ON (B)(6) 2010 AT 7 PM. THERE WAS NO ALTERATION TO HER DIABETES BASED ON THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT BECAUSE THE FOLD OUT INSTRUCTIONS IS TOO BIG TO USE OR TAKE WITH HER, SHE WAS UNABLE TO UTILIZE THE INSTRUCTION TO OPERATE THE LFS METER. AT 7:30 PM, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS DESCRIBED AS "HEADACHE AND SWEATY" DUE TO THE USER'S GUIDE ISSUE. THERE WAS NO ALLEGATION OF TREATMENT FOR ACUTE COMPLICATION OF DIABETES AS RESULT OF THE PRODUCT 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 SUBJECT METER WAS REPLACED WITH THE ONETOUCH ULTRA METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA DUE TO THE REPORTED ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening