BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2220189 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07850
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 K062195.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/23/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6), 2011 THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER¿S SPC PINS 1-3 WAS FOUND TO BE CONTAMINATED WITH DRIED BLOOD. ON (B)(6), 2011 THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER CONTINUED TO PROMPT THE WARNING OF "ER4" WHILE DOING A BLOOD GLUCOSE TEST. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011 AT 9AM. SHE STATED THAT SHE TESTS HER GLUCOSE 3X/DAY AND MANAGES HER DIABETES WITH METFORMIN, DIET AND EXERCISE, AND DUE TO THE ALLEGED ISSUE SHE DENIED MAKING ANY CHANGES TO HER REGULAR TREATMENT. THE PATIENT CLAIMED AT THE SAME TIME THE PRODUCT ISSUE STARTED, SHE ALSO BECAME DIZZY, NAUSEATED AND VOMITED. SHE STATED THAT SHE DID NOT SEEK OUT ANY TREATMENT DUE TO THESE SYMPTOMS. REPORTEDLY ON (B)(6) 2011, AT 7 PM, 2 DAYS AFTER SHE STOPPED USING THE METER DUE TO THE ALLEGED ERROR, HER SYMPTOMS WORSENED, AND NOW HAD CHEST PAIN, DIFFICULTY BREATHING, HAD A HEADACHE AND WAS SWEATY AND SICK TO HER STOMACH. THE PATIENT INFORMED THIS MSS, SHE WAS IMMEDIATELY TAKEN TO EMERGENCY ROOM (ER), HER GLUCOSE WAS TESTED WITH AN ER METER, OBTAINED A RESULT OF "320 MG/DL" AND WAS TREATED WITH INSULIN. REPORTEDLY SHE WAS HOSPITALIZED FOR 3 DAYS DUE TO HER SYMPTOMS OF HYPERTENSION AND HYPERGLYCEMIA, AND WAS FINALLY DISCHARGED ON (B)(6) 2011 AT 6 PM, ONCE HER GLUCOSE LEVELS STABILIZED. THE PATIENT DID NOT HAVE ANOTHER METER AVAILABLE AT TIME OF CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE, AND USING CORRECT UNEXPIRED STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND THE PATIENT ALLEGEDLY RECEIVED 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3075330

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R