BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3496798 · Received December 3, 2013

    Report

    Report Number
    2939301-2013-09649
    Event Type
    Injury
    Date Received
    December 3, 2013
    Report Date
    November 25, 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
    OR, 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 THAT THE ONETOUCH ULTRA2 DOES NOT TURN ON. THE PATIENT REPORTEDLY TESTED WITH STRIPS FROM LOT NUMBERS (3223559 AND 3478640). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). IT IS NOT KNOWN WHEN THE ALLEGED POWER ISSUE FIRST BEGAN. THE PATIENT REPORTEDLY DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN; IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, AS A RESULT OF THE PRODUCT ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF WEAKNESS AND SWEATING AN UNKNOWN TIME AFTERWARDS AND THE PATIENT REPORTEDLY CONSUMED FOOD AND OR DRINK AS SELF-TREATMENT AT AN UNKNOWN TIME LATER. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE SUBJECT METER¿S BATTERY DID NOT NEED TO BE REPLACED, THERE WAS NO MISUSE OF THE LFS PRODUCTS, THE PATIENT WAS USING THE CORRECT TESTS AT THE TIME OF THE ALLEGED ISSUE, AND THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624964 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3223559

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R