BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1820454 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07366
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT ON (B)(6) 2010 AT 6:45PM (APPROXIMATELY 1 HOUR AFTER EATING HER DINNER) SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A BLOOD GLUCOSE RESULT OF "153 MG/DL." THE PATIENT CLAIMED HER BLOOD GLUCOSE READINGS AFTER A MEAL ARE USUALLY LOWER THAN THE RESULT OBTAINED. IN RESPONSE TO THE ALLEGED HIGH RESULT, THE PATIENT REPORTED THAT SHE TOOK 1 UNIT OF HUMALOG INSULIN. AT 8PM THAT EVENING, THE PATIENT STATED THAT SHE BEGAN TO FEEL DISORIENTED AND AT A LATER TIME HER SPOUSE TOLD HER SHE HAD ALSO BECOME "COMBATIVE." THE PATIENT STATED THAT HER HUSBAND IMMEDIATELY CALLED EMERGENCY SERVICES. WHEN THEY ARRIVED, THE PATIENT CLAIMED HER BLOOD GLUCOSE WAS "23 MG/DL" WHEN TESTED WITH THE EMS METER. THE PATIENT REPORTED BEING TREATED WITH GLUCOSE GEL. THE PATIENT CONFIRMED SHE FELT BETTER AFTERWARDS AND REFUSED TO GO TO THE HOSPITAL. ON (B)(6) 2010, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "191 MG/DL" WITH THE SUBJECT METER AND "174 MG/DL" ON ANOTHER DEVICE (ONETOUCH ULTRA METER), PERFORMED WITHIN A COUPLE OF MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=30%. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT IN RESPONSE TO THE RESULTS OBTAINED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE 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.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION THE PUMP'S BATTERIES WERE FOUND TO BE DEPLETED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2985602

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R