BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4150670 · Received October 8, 2014

    Report

    Report Number
    2939301-2014-26742
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    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) 2014, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA LINK METER HAD A COMMUNICATION ISSUE WITH HER INSULIN PUMP. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT 11:30AM. THE REPORTER STATED A RESULT OBTAINED ON THE SUBJECT METER WAS NOT SENT TO THE MEDTRONIC PUMP DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN VIA THE PUMP. ON AN UNSPECIFIED TIME THE REPORTER STATED THAT THE PATIENT EXPERIENCED SYMPTOMS OF A ¿TRACE OF KETONE.¿ ON (B)(6) 2014 AT 01:30PM THE PATIENT WAS TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH BOLUS CORRECTION OF 9.7 UNITS OF HUMALOG INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE PATIENT WAS NOT GETTING A RESULT ON THEIR METER. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED; THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: THE ALLEGED PRODUCT ISSUE WITH THE LFS DEVICE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THIS EVENT. THE PATIENT DID DEVELOP SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND THE TREATMENT RECEIVED SUGGESTS THAT THE PATIENT¿S CONDITION DETERIORATED AS A RESULT OF NOT BEING ABLE TO TEST THEIR BLOOD GLUCOSE ACCURATELY; THEREFORE THE ALLEGED PRODUCT ISSUE MAY HAVE CONTRIBUTED TOWARDS SYMPTOMS INDICATIVE OF AN ACUTE DIABETES EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632638 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R