BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 3013380 · Received March 20, 2013

    Report

    Report Number
    3008382007-2013-05676
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K072543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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/REPORTER THE PATIENT'S DAUGHTER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH SELECT METER WAS GIVING INACCURATELY LOW READINGS. THE EVENT OCCURRED WHILE THE PATIENT WAS IN GHANA. ON (B)(6) 2013 THE SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE REPORTER TO OBTAIN AND VERIFY INFORMATION. BEGINNING ON (B)(6) 2013 THE PATIENT OBTAINED BLOOD GLUCOSE READINGS ON THE REPORTED METER THAT WERE LOW COMPARED TO HER EXPECTED VALUES OF 6.0 MMOL/L TO 8.0 MMOL/L; THE REPORTER WAS UNABLE TO PROVIDE THE SPECIFIC RESULTS THAT THE PATIENT OBTAINED. BASED ON THESE LOW READINGS, THE PATIENT TOOK THE ACTION OF CONSUMING INCREASED AMOUNTS OF JUICES. ON (B)(6) 2013 THE PATIENT EXPERIENCED THE SYMPTOMS OF RAPID HEARTBEAT AND FAINTING. THE PATIENT'S DAUGHTER TOOK HER TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED TO BE 38.0 MMOL/L (684 MG/DL) AND SHE WAS TREATED WITH INSULIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THREE DAYS WITH A DIAGNOSIS OF HYPERGLYCEMIA. THE PATIENT MANAGED HER DIABETES WITH THE ORAL MEDICATION GLUCOPHAGE (METFORMIN). THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AFTER OBTAINING LOW READINGS ON THE REPORTED METER, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116148 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L