BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1863856 · Received October 11, 2010

    Report

    Report Number
    2939301-2010-08970
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER/CONTROL SOLUTION. THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE CONTROL SOLUTION WAS ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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.

    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

    IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT LOSS OF CAPTURE WITH THE OUTPUT SET TO 3.8 VOLTS. WHEN THE OUTPUT WAS PROGRAMMED AT 5 VOLTS THE PROGRAMMER INDICATED "BATTERY DEPLETED". SINCE THE PATIENT EXPERIENCED REPEATED DIZZINESS, THE PACEMAKER WAS REPLACED IMMEDIATELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 ONETOUCH ULTRA2 METER IS PROMPTING THE SETTINGS MODE WHEN HE IS TESTING. ON (B)(6) 2010, THE PATIENT LOST HIS JOB AND REPORTEDLY COULD NOT AFFORD HIS DIABETES MEDICATION AND PROPER FOOD. THE PRODUCT ISSUE BEGAN APPROXIMATELY 1.5 MONTHS PRIOR TO CONTACTING LIFESCAN. SOMETIME AFTER THE ONSET OF THE PRODUCT ISSUE, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF "FREQUENT URINATION AND THIRST." ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED AFTER HE WAS TREATED WITH INSULIN THE EMERGENCY ROOM FOR A BLOOD GLUCOSE READING IN THE HIGH "600 MG/DL" OBTAINED ON THE HOSPITAL METER. 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 ALLEGED ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS AND RECEIVED MEDICAL INTERVENTION FOR HYPERGLYCEMIA FOR THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2782697

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R