BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2182959 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06564
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PIN 2 LIFTED HIGH. THE TEST STRIPS AND CONTROL SOLUTION WERE ALSO RETURNED BUT NOT EVALUATED SINCE THE PATIENT ADMITTED TO MISUSE OF THE PRODUCTS. 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN "ER5" PROMPT COMING UP WITH ON HIS ONE TOUCH ULTRAMINI METER WHEN TRYING TO DO A GLUCOSE CHECK. 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 APPROXIMATELY ONE WEEK PRIOR TO CONTACTING LFS. HE STATED THAT HE TESTS 5X/DAY AND MANAGES HIS DIABETES WITH ORAL MEDICATION AND INSULIN, AND DUE TO THE PRODUCT ISSUE, DENIED MAKING ANY CHANGES TO HIS USUAL ROUTINE. HE REPORTED THAT THE ERROR MESSAGE WAS INTERMITTENT, AND COULD SUCCESSFULLY USE THE SUBJECT METER "ONCE IN A WHILE" FOR A WEEK. THE PATIENT REPORTED THAT ON AN UNSPECIFIED TIME ON THE MORNING OF (B)(6) 2011, HE FELT SWEATY, LIGHTHEADED AND HAD BLURRY VISION, WAS UNABLE TO TEST WITH HIS METER DUE TO THE ERROR, SO HE MADE AN URGENT APPOINTMENT WITH HIS DOCTOR. AT 10 AM OF THE SAME DAY, THEY CHECKED HIS BLOOD GLUCOSE AT THE DOCTOR'S OFFICE AND OBTAINED A RESULT OF "40 MG/DL". THE PATIENT WAS IMMEDIATELY TREATED WITH A GLUCAGON INJECTION AND SAID THAT ABOUT AN HOUR LATER HE WAS FEELING BETTER. HE DID NOT HAVE ANOTHER DEVICE AT THE TIME OF CONCERN. DURING THE INITIAL CALL WITH CCA, THE PATIENT DESCRIBED USING CORRECT UNEXPIRED STRIPS. HOWEVER, THE CCA NOTED THAT THE PATIENT WAS APPLYING BLOOD TO THE WRONG END OF THE STRIP. AFTER PROPER INSTRUCTION, THE ISSUE WAS RESOLVED DURING THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3066546

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R