BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2220159 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07848
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    July 28, 2011
    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 PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY-USER/PATIENT'S HUSBAND CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH HIS WIFE'S ONE TOUCH ULTRA2 METER. ON (B)(6) 2011, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT'S HUSBAND TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S HUSBAND REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED DAY APPROXIMATELY 2 YEARS AGO. REPORTEDLY, THE PATIENT OBTAINED A "44 MG/DL" ON THE SUBJECT METER, AT AN UNSPECIFIED DAY OR TIME. IT IS UNKNOWN WHAT KIND OF DIABETES MANAGEMENT THE PATIENT FOLLOWED OR IF SHE MADE ANY CHANGES TO HER USUAL TREATMENT DUE TO THE ALLEGED ISSUE. ACCORDING TO THE DOCUMENTATION, THE PATIENT'S HUSBAND STATED THAT AT AN UNSPECIFIED DAY AND TIME, THE PATIENT BECAME INCOHERENT AND THEN BECAME UNCONSCIOUS, AFTER THE ALLEGED PRODUCT ISSUE STARTED. EMERGENCY MEDICAL SERVICE (EMS) WAS REPORTEDLY CALLED AND TESTED THE PATIENT WITH THEIR EMS METER WHERE THEY OBTAINED A GLUCOSE RESULT OF "6 MG/DL". THE REPORTER STATED THAT SHE WAS TREATED (UNKNOWN TREATMENT, POSSIBLY IV FLUIDS) AND THEN WAS TAKEN TO THE HOSPITAL FOR FURTHER TREATMENT. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT'S HUSBAND NEEDED TO GET OFF THE PHONE TO TAKE CARE OF HIS WIFE AND WERE UNABLE TO COMPLETE TROUBLESHOOTING SESSION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S HUSBAND CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AND RECEIVED MEDICAL INTERVENTION FROM A HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3030911

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R