BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2993756 · Received March 7, 2013

    Report

    Report Number
    3008382007-2013-04438
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    March 4, 2013
    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
    GM
    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED 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) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT'S ONETOUCH ULTRAEASY METER READ INACCURATELY HIGH. THE CUSTOMER CARE ADVOCATE (CCA) SPOKE WITH THE REPORTER TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE REPORTER DID NOT HAVE ANY MORE INFORMATION IN ORDER TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE DOCUMENTATION OF THE CCA DURING THE INITIAL CONVERSATION WITH THE REPORTER. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. IT WAS REPORTED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS WHICH WERE "JUST HIGH". SPECIFIC RESULTS WERE NOT PROVIDED. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES; HOWEVER, BASED ON THE ALLEGED RESULTS, THE PATIENT REPORTEDLY ADMINISTERED AN INCREASED DOSE OF INSULIN (AMOUNT NOT SPECIFIED). AFTER, THE REPORTER CLAIMS THE PATIENT FELT SYMPTOMS OF HYPOGLYCEMIA. SYMPTOMS WERE NOT SPECIFIED. TREATMENT WAS ALSO NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. TESTING SUPPLIES WERE NOT AVAILABLE FOR QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97556 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening