BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1911095 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10366
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 9, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/02/2010. 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

    CUSTOMER REPORTED THAT THE BATTERY CHARGER VOLTAGE WAS TOO LOW ON THIS X-RAY SYSTEM. THE SYSTEM WOULD NOT INITIALIZE AND SEVERAL RESTART ATTEMPTS WERE WITHOUT SUCCESS. A SEDATED PT WAS ON THE TABLE. THE SYSTEM WAS NOT ABLE TO PROVIDE X RAY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THERE WAS NO RESPONSE WITH THE UP ARROW BUTTON ON HER ONETOUCH ULTRA2 METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION: PRIOR TO THE ALLEGED ISSUE THE PATIENT INDICATED SHE WAS NOT TESTING HER BLOOD GLUCOSE ON A DAILY BASIS AS RECOMMENDED BY HER PHYSICIAN. THE PATIENT INDICATED SHE WAS PRESCRIBED 10MG OF GLIPIZIDE AND 1000MG OF METFORMIN, BOTH TO BE TAKEN TWICE A DAY. THE PATIENT CORRECTED AND CLARIFIED THAT THE ALLEGED ISSUE BEGAN ON AN UNSPECIFIED DATE IN (B)(6) 2010; THE PATIENT INDICATED SHE HAD NOT MONITORED HER BLOOD GLUCOSE SINCE (B)(6) 2010 (WHILE ABROAD) SINCE SHE HAD FORGOTTEN TO PACK HER BLOOD GLUCOSE TESTING SUPPLIES. AT THE TIME OF THE ALLEGED ISSUE THE PATIENT STATED SHE WANTED TO BEGIN MONITORING HER BLOOD GLUCOSE AGAIN. THE PATIENT INDICATED SHE WAS ABLE TO OBTAIN A BLOOD GLUCOSE RESULT WITH THE SUBJECT METER; HOWEVER, THE PATIENT STATED SHE WAS UNABLE TO INCLUDE A COMMENT WITH HER BLOOD GLUCOSE RESULT WHEN USING THE UP ARROW BUTTON. DESPITE BEING ABLE TO OBTAIN A BLOOD GLUCOSE RESULT, THE PATIENT CLARIFIED SHE DID NOT WANT TO CONTINUE MONITORING HER BLOOD GLUCOSE WITH THE SUBJECT METER. THE PATIENT WAS UNDER THE IMPRESSION THAT THE ALLEGED ISSUE WOULD AFFECT THE ACCURACY OF THE SUBJECT METER. IN ADDITION, THE PATIENT CLAIMED THAT AS A RESULT OF THE ALLEGED ISSUE, SHE WOULD EITHER FORGET TO TAKE HER MEDICATIONS OR SHE WOULD TAKE HER MEDICATIONS AT THE WRONG TIME OF THE DAY. ON (B)(6) 2010 (AT APPROXIMATELY 630AM) THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF "DIZZINESS AND FELT LIKE THROWING UP"; IN RESPONSE TO HER SYMPTOMS, THE PATIENT STATED SHE WENT TO THE EMERGENCY ROOM (ER). THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "500 MG/DL" WITH THE ER/HOSPITAL'S METER AND WAS ADMINISTERED IV FLUIDS AND INSULIN BY THE HEALTH CARE PROFESSIONAL (HCP). THE PATIENT WAS RELEASED FROM THE ER FIVE HOURS LATER. DURING TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT. THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE UP ARROW BUTTON ALLEGEDLY DID NOT FUNCTION, IT DOES NOT PREVENT THE PATIENT FROM OBTAINING AN ACTIONABLE BLOOD GLUCOSE RESULT; THE PATIENT ALSO CONFIRMED SHE WAS ABLE TO OBTAINED A BLOOD GLUCOSE READING JUST PRIOR TO WHEN THE ALLEGED ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPERGLYCEMIA AFTER 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. 2925413

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R