BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2101215 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04348
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 2011
    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

    THE 510 (K) # IS K001109. 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 LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING AN ERROR 5 MESSAGE ON HER ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6) 2011. THE PATIENT MENTIONED THAT DUE TO THE ALLEGED ERROR 5 MESSAGE, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE ON HER LFS METER. SHE HAD ANOTHER NON- LFS METER TO TEST HER BLOOD GLUCOSE DURING THE MEANTIME AND ADJUSTED HER INSULIN ACCORDINGLY TO THE OTHER METER. ON (B)(6) 2011, SHE ENDED DEVELOPING SYMPTOMS OF BECOMING UNRESPONSIVE AFTER TAKING INSULIN BASED ON THE OTHER METER READING. SHE DOES NOT RECALL WHAT THE RESULT WAS AT THE TIME. HER BLOOD GLUCOSE WAS TESTED BY FAMILY MEMBERS; HOWEVER, SHE DOES NOT RECALL THE READING AND EMS WERE CONTACTED. EMS TESTED THE PATIENT AND TREATED WITH HER WITH GLUCAGON INJECTION S AND WAS TAKEN TO THE ER. SHE WAS IN THE ER FOR 2 HOURS AND THEN RELEASED FROM THE HOSPITAL WITH BLOOD GLUCOSE OF 240 MG/DL. SHE DOES NOT RECALL HOW SOON AFTER TREATMENT SHE REGAINED CONSCIOUSNESS. THE DIAGNOSIS WAS HYPOGLYCEMIA. SHE CLAIMS HER PHYSICIAN ADJUSTED HER SLIDING SCALE DUE TO THE ER VISIT. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 5 MESSAGE, SHE WAS UNABLE TO TEST AND LATER SUFFERED A SERIOUS INJURY AFTER ADJUSTING HER INSULIN ACCORDING TO ANOTHER DEVICE AND HAD TO RECEIVE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3080075

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R