BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2213889 · Received August 17, 2011

    Report

    Report Number
    2939301-2011-07529
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/14/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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. THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH HER ONE TOUCH ULTRA2 METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE REPORTER STATED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED TIME OF THE AFTERNOON OF (B)(6) 2011. THE PATIENT REPORTEDLY OBTAINED A RESULT OF '600 MG/DL' AND/OR '140 MG/DL' ON THE SUBJECT METER, SHE COULD NOT REMEMBER WHEN OR IF THESE READINGS WERE DONE ON THE SAME DAY. THE PATIENT FELT THOSE READINGS WERE INACCURATE HIGH COMPARED TO THE LAB RESULT OF '55 MG/DL' OBTAINED THE WEEK BEFORE. THE PATIENT REPORTED TESTING HER BLOOD GLUCOSE 4X/DAY, AND DENIED TAKING ANY MEDICATIONS TO MANAGE HER DIABETES. DUE TO THE ALLEGED INACCURATE HIGH RESULT ON AN UNSPECIFIED TIME OF THE EVENING, SHE DECREASED HER INTAKE OF FOOD AND DRINK. SHE REPORTEDLY CLAIMED THAT SOMETIME IN THE EARLY AFTERNOON, BEFORE THE ISSUE BEGAN, SHE FELT WEAK, HER HEARTBEAT WAS FAST, WAS LIGHTHEADED AND HAD A HEADACHE. SHE COULD NOT RECALL HOW SOON BEFORE THE SYMPTOMS HAD STARTED OR WHAT KIND OF RESULTS SHE HAD OBTAINED AT THAT TIME. THE PATIENT MENTIONED THAT SHE ASSOCIATED THESE SYMPTOMS TO A LOW GLUCOSE LEVEL, BUT COULD NOT RECALL ADMINISTERING ANY SELF TREATMENT. SHE REPORTED THAT LATER THAT EVENING SINCE HER SYMPTOMS REMAINED THE SAME, (SHE COULD NOT RECALL TESTING ON THE METER AT THIS TIME) SHE WAS TAKEN TO EMERGENCY ROOM BY HER DAUGHTER. THE PATIENT'S GLUCOSE WAS TESTED, SHE WAS UNABLE TO RECALL THE RESULT OBTAINED, BUT MENTIONED IT WAS 'LOW' AND ALLEGEDLY WAS GIVEN FOOD AND DRINK AS TREATMENT. SHE COULD NOT RECALL THE REST OF THE TREATMENT PROVIDED. THE PATIENT WAS DISCHARGED SHORTLY AFTER. THERE WAS NO OTHER DEVICE AVAILABLE AT TIME OF CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE METER WITH THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY WHICH REQUIRED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2730749

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening