BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1844424 · Received September 24, 2010

    Report

    Report Number
    2954323-2010-01331
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 24, 2010
    Report Date
    October 25, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS WERE RETURNED AND INVESTIGATED. THE COMPLAINTS WERE NOT CONFIRMED. VISUALLY INSPECTED PACKAGE. RETURNED PACKAGING WAS RETURNED OPENED AND THUS IT CANNOT BE DETERMINED WHETHER TAMPERING HAS TAKEN PLACE AND THE METER HAD READINGS IN THE METER UPON INVESTIGATION. PERFORMED 3 CONTROL SOLUTION TEST. RESULTS WERE 344, 341, 344 MG/DL WHICH WERE WITHIN THE RANGE SPECIFICATION FOR THE DEVICE. COMPARED DOWNLOADED LOG WITH THE GLUCOSE HISTORY IN THE METER. DID NOT OBSERVE INCORRECT DATA IN MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT SHE JUST RECEIVED A FREESTYLE FREEDOM LITE METER. CUSTOMER REPORTED THERE WAS A READING IN METER'S MEMORY THAT WAS NOT HERS. CUSTOMER ALSO REPORTED BECAUSE OF THE METER ISSUE, SHE EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER FURTHER REPORTED VISITING HER DOCTOR WHO DIAGNOSED CUSTOMER WITH SEVERE HYPERGLYCEMIA AND STARTED CUSTOMER ON A NEW ORAL DIABETES MEDICATION. NO EMERGENT THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR SPHINGOMONAS, PSEUDOMONAS, KLEBSIELLA PNEUMONIAE AND E. COLI IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IN 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT DID TRANSFER TO HEMODIALYSIS. PD THERAPY WAS WITHDRAWN. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE REPORTER BELIEVED THAT THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR SPHINGOMONAS, PSEUDOMONAS, KLEBSIELLA PNEUMONIAE AND E. COLI WAS NOT RELATED TO THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention