BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2190245 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06831
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/29/2011)-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. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH AS COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED THAT ON (B)(6) 2011 AT 11:00AM, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "195 MG/DL" WITH A LIFESCAN METER AND "UNKNOWN RESULT" ON ANOTHER METER, PERFORMED MORE THAN 30 MINUTES OF EACH OTHER. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH A COMBINATION OF ORAL MEDICATIONS, 500MG OF METFORMIN AND 30MG OF ACTOSE, AND DENIED MAKING ANY CHANGES TO HIS NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. FIVE HOURS AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "SHAKY" AND ON (B)(6) 2011 AT AROUND 4:00AM, CALLED EMS WHO TESTED HIS BLOOD GLUCOSE ON THEIR DEVICE (UNKNOWN RESULT) AND SHORTLY AFTER TREATED HIM WITH GLUCAGON INJECTION. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL INTERVENTION 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening