BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1844080 · Received September 24, 2010

    Report

    Report Number
    2939301-2010-08441
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    May 22, 2010
    Report Date
    August 30, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K021819.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

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON SEPTEMBER 24, 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2010, HE OBTAINED AN AFTER DINNER RESULT OF APPROXIMATELY "270 MG/DL' WITH THE SUBJECT METER. IN RESPONSE TO THE READING, THE PATIENT CLAIMED HE TOOK 6 UNITS OF NOVOLOG INSULIN (BASED ON HIS SLIDING SCALE). APPROXIMATELY 4 OR 5 HOURS AFTER TAKING THE INSULIN, THE PATIENT SATED THAT HIS WIFE FOUND HIM "PASSED OUT." THE PATIENT DOES NOT KNOW IF HIS SPOUSE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AT THE TIME SHE FOUND HIM. EMERGENCY SERVICES WAS CONTACTED AND WHEN THEY ARRIVED THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE WAS "21 MG/DL' WHEN TESTED WITH AN EMS METER. THE PATIENT CLAIMED HE WAS ADMINISTERED IV GLUCOSE AND TAKEN TO THE HOSPITAL. THE PATIENT DOES NOT RECALL WHAT HIS BLOOD GLUCOSE WAS AT THE TIME HE ARRIVED TO THE HOSPITAL. THE PATIENT WAS ONLY ABLE TO CONFIRM THAT HE WAS HOSPITALIZED FOR APPROXIMATELY 9 DAYS. THE PATIENT REPORTED THAT HE BELIEVES HE WAS HOSPITALIZED AS A RESULT OF HIS LOW BLOOD GLUCOSE AND ALSO AS A RESULT OF COMPLICATIONS THAT AROSE FROM A KIDNEY TRANSPLANT. THE PATIENT INFORMED THE MSS THAT ON AN UNSPECIFIED DAY IN AUGUST 2010 HE OBTAINED BLOOD GLUCOSE READINGS IN THE "500, 200 AND 300 MG/DL" RANGE, PERFORMED WITHIN MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20%. THE PATIENT CONTACTED HIS PHYSICIAN AS A RESULT OF THE ERRATIC RESULTS AND WAS ADVISED BY HIS DOCTOR TO OBTAIN A NEW METER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER AND STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R