BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1910512 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10361
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 5, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/06/2010. 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.

    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.

    Description of Event or Problem · 1

    THE PUMP WAS CHECKED WITH THE PHYSICIAN PROGRAMMER. THE PROGRAMMER INDICATED THE RESERVOIR CONTAINED 1.6 ML OF MEDICATION. THE HCP ASPIRATED 20 ML OF MEDICATION FROM THE RESERVOIR; THUS NONE OF THE DRUG WAS DELIVERED TO THE PT. THE PUMP WAS EXPLANTED AND NOT REPLACED. THE PUMP DELIVERED MORPHINE 50 MG/2 ML. PT OUTCOME WAS NOT REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 7PM. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ON THE FOLLOWING MORNING, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF DIZZY AND SWEATING. AT 1030AM THAT MORNING, THE PATIENT TOOK MORE FOOD AND/ OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. IT WAS DISCOVERED THAT THE SUBJECT METER WOULD NOT POWER ON WITH TEST STRIP INSERTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043957

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R