BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1883618 · Received October 26, 2010

    Report

    Report Number
    2939301-2010-09476
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 11, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510K # K073231.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    PER THE SURGEON, THE DEVICE WAS EXPLANTED DUE TO A PARTIAL EXTRUSION OF THE ELECTRODE ARRAY. THE DEVICE WAS EXPLANTED ON (B)(6), 2010 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRALINK METER DOES NOT TURN ON. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. THE POWER ISSUE BEGAN ON THE NIGHT OF (B)(6) 2010. THE PATIENT DID NOT MAKE ANY ALTERATION TO HIS DIABETES MANAGEMENT AT THE TIME OF CONCERN. THE FOLLOWING DAY ON (B)(6) 2010, THE PATIENT SOUGHT PHONE ADVICE FROM HER HEALTHCARE PROVIDER. SHE WAS ADVISED TO CONTACT LIFESCAN AND USE ANOTHER METER TO MANUALLY ENTER HIS BLOOD GLUCOSE INTO THE PUMP. THE PATIENT DID NOT HAVE ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO EVIDENCE THAT THE PATIENT SUFFERED A SERIOUS INJURY DUE TO THE PRODUCT ISSUE. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND DID NOT RECEIVE ANY MEDICAL INTERVENTION TO SUGGEST HYPOGLYCEMIA OR HYPERGLYCEMIA. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3001156

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR