BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2792561 · Received October 16, 2012

    Report

    Report Number
    2939301-2012-12060
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 25, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER FAILED TESTING, THE BATTERY CONTACT WAS CONTAMINATED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS REVERTING TO THE SET UP MODE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2012. THE PATIENT REPORTED MANAGING HER DIABETES WITH INSULIN PUMP THERAPY AND DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT DUE TO THE ALLEGED ISSUE SHE SKIPPED A BOLUS DOSE OF INSULIN (A FEW HOURS AFTER THE ALLEGED ISSUE BEGAN) WHICH CAUSED HER TO DEVELOP SYMPTOMS OF "HEADACHE, DRY MOUTH, AND NAUSEA." THE PATIENT TOLD THE CCA THAT SHE ASSOCIATED THE REPORTED SYMPTOMS WITH HIGH BLOOD GLUCOSE. HOWEVER, THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO KNOWN MISUSE TO THE SUBJECT METER. DURING TROUBLESHOOTING THE CCA DOCUMENTED THAT THE ALLEGED ISSUE DID NOT BEGIN AFTER THE PATIENT REPLACED THE BATTERIES. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCT WAS STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SHE ASSOCIATED WITH HIGH BLOOD GLUCOSE DUE TO MISSING AN INSULIN DOSE AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3313606

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening