BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2468222 · Received February 24, 2012

    Report

    Report Number
    2939301-2012-01948
    Event Type
    Injury
    Date Received
    February 24, 2012
    Report Date
    February 7, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAPING METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE BEGAN ON EITHER (B)(6) 2012 OR ON (B)(6) 2012 AT 2:00PM. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP AND "SKIPPED HER USUAL NOVOLOG INTAKE" IN RESPONSE TO THE REPORTED ISSUE. IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "LIGHTHEADEDNESS, NAUSEA, AND SHAKINESS" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. DURING TROUBLESHOOTING, CCA NOTED THAT THE BATTERIES DID NOT NEED REPLACEMENT. REPLACEMENT METER WAS SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT AFTER THE ALLEGED ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3232602

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening