BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4131060 · Received October 1, 2014

    Report

    Report Number
    2939301-2014-25992
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/14/2014), THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 10/08/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/11/2014 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. 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.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER DISPLAYED THE BATTERY INDICATOR WARNING. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED BY THE MEDICAL SURVEILLANCE SPECIALIST TO CONDUCT FOLLOW UP QUESTIONS. THE PATIENT STATED THAT THE ISSUE FIRST STARTED ON (B)(6) 2014 AT 11AM. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION(S) AS WELL AS WITH DIET AND/OR EXERCISE. THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THEIR REGULAR DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE PRODUCT ISSUE. THE PATIENT REPORTED THAT RIGHT AFTER THE PRODUCT ISSUE FIRST OCCURRED THEY EXPERIENCED THE SYMPTOMS OF ¿SWEATY AND FEELING SICK¿. THE PATIENT DENIED RECEIVING ANY FORM OF TREATMENT DUE TO THE REPORTED PRODUCT ISSUE. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE BATTERIES NEEDED TO BE CHANGED ON THE METER, HOWEVER THE PATIENT DID NOT HAVE ANY BATTERIES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE 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
    612567 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3682341

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening