BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 5781854 · Received July 11, 2016

    Report

    Report Number
    3008382007-2016-35176
    Event Type
    Injury
    Date Received
    July 11, 2016
    Report Date
    June 14, 2016
    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
    EC
    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 JUNE 14, 2016 LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR ONE TOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND CUSTOMER CARE ADVOCATE (CCA) ATTEMPTING TO FOLLOW-UP WITH THE PATIENT. THE CCA WAS ADVISED BY THE PATIENT THAT THE ISSUE OCCURRED VERY DAY IN (B)(6). THE PATIENT REPORTED ON AN UNSPECIFIED DAY/TIME , WHEN THEY ALLEGEDLY OBTAINED INACCURATE HIGH RESULTS OF ¿220, 200, 237, 300 AND 350 MG/DL¿ WITH THE SUBJECT METER. IT IS UNKNOWN IF THE RESULTS WOULD/WOULD NOT MEET LIFESCAN¿S PRECISION CRITERIA AS THE COMPARISON IS AGAINST THEIR FEELINGS AND/OR NORMAL READINGS. THE PATIENT STATED THEY MANAGE THEIR DIABETES WITH INSULIN (SELF-ADJUSTER). IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT. THE PATIENT CLAIMS THEY DEVELOPED SYMPTOMS OF ¿SWEAT, LOW BLOOD PRESSURE AND VOMITING¿ BEFORE THE PRODUCT ISSUE BEGAN. THE PATIENT ALLEGED HCP TREATMENT, DURING A DOCTOR OFFICE VISIT. THE PATIENT WAS ALLEGEDLY WAS TREATED WITH SERUM (UNKNOWN), IN HOSPITAL, 2 MONTHS AGO. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE TEST STRIP WERE NOT OPEN PAST THEIR DISCARD OR EXPIRY DATES AND THE TEST STRIPS WERE STORED CORRECTLY. THE CCA WAS UNABLE TO WALK THROUGH A RETEST AS THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED HCP TREATMENT, AS IT IS UNKNOWN WHAT THE PATIENTS BLOOD GLUCOSE RESULTS WERE PRIOR TO THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435532 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3874495

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R