BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT INDUO METER

    MDR report key: 2034019 · Received March 30, 2011

    Report

    Report Number
    2939301-2011-02691
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 22, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (07/08/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER'S LCD CABLE/CABLE CONNECTOR WAS FOUND PEELED OFF AT PINS 1, 27, 28, AND 29. 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. 510(K) # IS K024194.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH INDUO METER HAD MISSING SEGMENTS. 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) 2011 AT 11AM. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DEVELOPED SYMPTOMS OF SWEATING AND CONFUSION (SYMPTOMS THE PATIENT ASSOCIATED WITH LOW BLOOD GLUCOSE) ON (B)(6) 2011 AT 7PM AND ALSO ON (B)(6) 2011 (TIME NOT SPECIFIED). AT AN UNSPECIFIED DATE/TIME LATER, THE PATIENT INDICATED HE FOLLOWED HIS USUAL (UNSPECIFIED) ROUTINE FOR TREATING HIS LOW BLOOD GLUCOSE SYMPTOMS. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME AND THAT THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT INDUO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2941279

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| R