BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1920314 · Received December 10, 2010

    Report

    Report Number
    2954323-2010-01670
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 14, 2010
    Report Date
    February 10, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT WAS RETURNED. THE METER WAS DISASSEMBLED METER AND CORROSION WAS OBSERVED ON THE PRINTED CIRCUIT BOARD. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED. ALTHOUGH THE CUSTOMER REPORTED A PRODUCT ISSUE HAD CONTRIBUTED TO THE MEDICAL EVENT, THE DATES PROVIDED BY THE CUSTOMER INDICATE THE MEDICAL EVENT OCCURRED PRIOR TO THE REPORTED PRODUCT ISSUE.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT THE RECEIVED AN ERROR 5 MESSAGE ON THEIR METER AND AS A RESULT THE CUSTOMER WAS NOT ABLE TO TEST AND ON (B)(6) 2010 THEY EXPERIENCED SYMPTOMS OF BLURRY VISION WHILE AT CHURCH. THE CUSTOMER THEN STATED THEY WERE SEEN AT A HEALTH CARE FACILITY, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INTRAVENOUS FLUIDS AND RECEIVED AN INSULIN INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention