BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2032550 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02678
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS 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. 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER DISPLAYED A BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT 5 WEEKS AGO PRIOR TO CONTACTING LFS. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN (AMOUNT NOT SPECIFIED). THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATION. THE REPORTER DENIED THE PATIENT DEVELOPED SYMPTOMS. ON (B)(6) (YEAR NOT SPECIFIED), THE PATIENT VISITED HER PHYSICIAN'S OFFICE AND A GLYCATED HEMOGLOBIN (A1C) TEST WAS PERFORMED ON THE PATIENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE BATTERIES WERE RECENTLY REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3080830

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR