BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 3243995 · Received July 24, 2013

    Report

    Report Number
    3008382007-2013-20821
    Event Type
    Injury
    Date Received
    July 24, 2013
    Report Date
    July 5, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT¿S ONETOUCH ULTRAEASY METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE CUSTOMER CARE ADVOCATE (CCA) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION DURING THE INITIAL CALL. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿4.1 MMOL/L¿ WITH THE SUBJECT METER AND ¿1.4 MMOL/L¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7 MMOL/L. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF CHANGES WERE MADE TO HER USUAL MANAGEMENT ROUTINE. THE REPORTER CLAIMED THE PATIENT WAS ¿ACTING LIKE SHE WAS HAVING A HYPO.¿ SPECIFIC SYMPTOMS WERE NOT PROVIDED. TREATMENT WAS NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY MAY HAVE DEVELOPED SYMPTOMS AND OBTAINED A BLOOD GLUCOSE RESULT WITH ANOTHER DEVICE SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346374 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3425912

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening