BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2760364 · Received September 26, 2012

    Report

    Report Number
    2939301-2012-11102
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 12, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER'S BACK BUTTON, DOWN ARROW BUTTON, UP ARROW BUTTON WERE FOUND TO FUNCTION PROPERLY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER HAD INTERMITTENT NO RESPONSES FROM THE METER UP, DOWN AND BACK BUTTONS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. TWO MONTHS PRIOR TO CONTACTING LFS, THE PATIENT REPORTED THE ALLEGED ISSUES FIRST OCCURRED. THE PATIENT REPORTED USING NOVOLOG INSULIN PUMP THERAPY TO MANAGE HER DIABETES. THE PATIENT REPORTED TESTING ON AN UNKNOWN BACK UP METER AT AN UNKNOWN TIME AND OBTAINED AN UNKNOWN READING, HOWEVER SHE ADMINISTERED 6-9 UNITS OF NOVOLOG INSULIN BASED ON THAT READING. THE PATIENT REPORTED 1 HOUR LATER, SHE DEVELOPED SYMPTOMS OF "EXCESSIVE THIRST AND URINATION" WHICH SHE ASSOCIATED WITH HYPERGLYCEMIA. THE PATIENT DENIED RECEIVING FURTHER MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THESE WERE INTERMITTENTLY RECURRING ISSUES. THE CCA NOTED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE PRODUCT. THE ALLEGED ISSUES WERE NOT RESOLVED WITH A WALK THROUGH RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THESE COMPLAINTS ARE BEING REPORTED AS ADVERSE EVENTS BECAUSE THE PATIENT REPORTED DUE TO THE ALLEGED ISSUES, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening