BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2468210 · Received February 24, 2012

    Report

    Report Number
    2939301-2012-01947
    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
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    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. THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAPING METER HAD "BLACK MARKS" ON THE DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT THE ALLEGED ISSUE WAS DISCOVERED AT AN UNSPECIFIED DATE AND TIME AT THE (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT MANAGES HIS DIABETES WITH THE INSULIN PUMP AND "DID NOT BOLUS" IN RESPONSE TO THE REPORTED ISSUE. THREE HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "SWEATS AND THIRST". THE CCA WAS INFORMED BY THE REPORTER THAT THE PATIENT USED HIS BACKUP METER, ONETOUCH ULTRALINK METER, TO TEST HIS BLOOD SUGAR LEVEL AND "BOLUSED MORE THAN HIS USUAL AMOUNT" BASED ON THE READING OBTAINED FROM THE BACKUP METER. DURING TROUBLESHOOTING, THE CCA DETERMINED THAT THERE WAS ANY EVIDENCE OF MISUSE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT ADMINISTERED SELF-TREATMENT BASED ON THE RESULT FROM ANOTHER LFS BLOOD GLUCOSE-MONITORING DEVICE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3170043

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening| R