BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3980156 · Received August 5, 2014

    Report

    Report Number
    2939301-2014-19696
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 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
    MS, US
    Reporter Occupation
    OTHER

    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. DATE OF EVENT: (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/05/2014). THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 08/27/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 08/29/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRAMINI METER WAS GIVING INACCURATELY HIGH READINGS. . THE (B)(6) CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 AT 9:00 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 253 MG/DL AND 254 MG/DL ON THE REPORTED METER, WHICH SHE CLAIMED WERE INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES. BASED ON THESE READINGS, THE PATIENT THEN TOOK HER USUAL DOSE OF NOVOLOG INSULIN, SPECIFIC NUMBER OF UNITS NOT PROVIDED. THIRTY MINUTES AFTERWARDS, THE PATIENT FELT HER BLOOD GLUCOSE LEVEL DROPPED AND SHE EXPERIENCED THE SYMPTOM OF CONFUSION. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN TAKEN ON A SLIDING SCALE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON ELEVATED METER READINGS AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458213 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3606628

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R