BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1861489 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08939
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    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. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A STICKY BUTTON/SWITCH. 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

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW THYROID PEROXIDASE ANTIBODY (TPO AB) RESULTS WITHIN NORMAL REFERENCE RANGE GENERATED ON UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR SEVERAL PATIENTS. SUBSEQUENT TESTING ON AN ALTERNATE REAGENT PACK PRODUCED RESULTS ABOVE THE NORMAL REFERENCE RANGE. THE ERRONEOUS TPO AB RESULTS WERE REPORTED OUT OF THE LABORATORY. APPROXIMATELY 8-9 PATIENT RESULTS WERE CORRECTED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA 2 METER WOULD POWER OFF DURING USE, AND WAS DISPLAYING THE SETUP MODE DURING TESTING. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010, THE PATIENT NOTED THE REPORTED METER WOULD POWER OFF DURING USE, AND WOULD DISPLAY THE SETUP MODE DURING TESTING; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ON (B)(6) 2010 AT 10:00 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF DIFFICULTY BREATHING, DEHYDRATION AND NAUSEA. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM, WHERE HIS BLOOD GLUCOSE LEVEL WAS TESTED TO BE 278 MG/DL. THE PATIENT WAS TREATED INTRAVENOUSLY WITH FLUIDS, AND ADMITTED TO THE HOSPITAL. ON (B)(6) 2010 HIS BLOOD GLUCOSE LEVEL WAS 330 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN R INSULIN TAKING 60 UNITS OVER A TWELVE HOUR PERIOD. THE PATIENT DID NOT HAVE A BACKUP METER. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE CUSTOMER CARE ADVOCATE DETERMINED THE PATIENT HAD CORRECTLY REPLACED THE METER'S BATTERY AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. THE ISSUES WERE NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL FOR TWO WEEKS DUE TO THE METER POWER ISSUE, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3028407

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L