BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2934016 · Received January 30, 2013

    Report

    Report Number
    3008382007-2013-01838
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "132, 117, 172, 85, 58, 94, 68 AND 151 MG/DL" WITH THE SUBJECT METER. THE CCA NOTED THE PATIENT OBTAINED BLOOD GLUCOSE SAMPLES FROM AN UNAPPROVED SAMPLE SITE. THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN AND LANTUS INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DOSE OF MEDICATIONS. AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKING, EXTREME HUNGER, BLURRED VISION AND "ON THE VERGE OF PASSING OUT." THE PATIENT REPORTEDLY TOOK MORE FOOD AND/ OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT OBTAINED BLOOD GLUCOSE SAMPLES FROM UNAPPROVED SAMPLE SITES. REPLACEMENT PRODUCTS WERE STILL 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
    40935 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3361274

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Life Threatening| R