BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2102327 · Received May 25, 2011

    Report

    Report Number
    2939301-2011-04380
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 510 (K) # IS K053529. 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 (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS TO THE CUSTOMER CARE ADVOCATE (CCA) AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2011, THE PATIENT OBTAINED A 380 MG/DL AND TOOK 10 UNITS OF RAPID INSULIN. SHE TOOK THE INSULIN BASED ON HER SLIDING SCALE. SHE DID NOT ATTEMPT TO RETEST; HOWEVER, STARTED TO EXHIBIT SYMPTOMS OF FEELING DIZZY, SWEATY AND A HEADACHE APPROXIMATELY 20 MINUTES LATER. SHE DID NOT ATTEMPT TO RETEST HER BLOOD GLUCOSE, WHEN SHE EXHIBITED THE SYMPTOMS. HER DAUGHTER THEN TOOK HER TO THE HOSPITAL WHERE HER BLOOD GLUCOSE WAS 70 MG/DL AND SHE WAS TREATED WITH "FLUIDS". SHE WAS IN THE HOSPITAL FOR APPROXIMATELY 20 HOURS AND HER DIABETES REGIMEN WAS NOT CHANGED DUE TO THE ALLEGED ISSUE. PER PATIENT THE DIAGNOSIS IN THE HOSPITAL WAS "HYPOGLYCEMIA". THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGEDLY TOOK INSULIN BASED ON HER METER RESULT AND APPROXIMATELY 20 MINUTES LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO RECEIVE MEDICAL TREATMENT IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3102318

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R