BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2803086 · Received October 24, 2012

    Report

    Report Number
    2939301-2012-12290
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 2, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS FAILED TESTING, THE DATA WAS FOUND TO BE CORRUPTED. THE TEST STRIPS WERE ALSO RETURNED ON (B)(4) 2012 BUT WERE NOT TESTED BECAUSE THE ALLEGED COMPLAINT WAS RELATED TO THE METER ONLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND 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 THAT HIS ONETOUCH PING METER WAS DISPLAYING AN ERROR 1 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED ISSUE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING AND WEAKNESS THREE DAYS LATER, AND THE PATIENT IMMEDIATELY ADMINISTERED FOOD AND/OR DRINK AS SELF-TREATMENT AT THE ONSET OF HIS REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. A REPLACEMENT METER WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3199037

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R