BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3093167 · Received May 3, 2013

    Report

    Report Number
    3008382007-2013-10190
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 9, 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
    AL, US
    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

    ON (B)(6) 2013, THE PATIENT CONTACTED LFS IN REGARDS TO A REQUEST FOR A FOLLOW-UP. THE PATIENT CLAIMED HE DID NOT EAT ENOUGH CARBOHYDRATE FOR ONE OF HIS MEALS, RESULTING IN A HYPOGLYCEMIA DURING THE EVENT IN QUESTION. THE PATIENT DID NOT REPORT OF ANY INACCURATE HIGH RESULTS THAT WOULD CONTRIBUTE TO THE SERIOUS INJURY THAT DAY. THE PATIENT HAS RECEIVED THE NEW LFS PRODUCT AND REPORTED HIS BLOOD GLUCOSE IS STILL READING IN THE 200S MG/DL, WHICH WAS CONSISTENT WITH THE SUBJECT METER READING. THE DOCTOR HAS PRESCRIBED A NEW MEDICATION BASED ON THE ELEVATED BLOOD GLUCOSE READING. THIS COMPLAINT IS BEING RULED OUT BASED ON THE NEW INFORMATION PROVIDED. THERE IS NO EVIDENCE THE LFS PRODUCT CONTRIBUTED TO THE ALLEGED INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READINGS IN THE 200 RANGE. IN ADDITION, THE PATIENT MENTIONED THE SUBJECT METER READING IS READING 40 POINTS HIGHER THAN ANOTHER METER. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT'S DIABETES IS MANAGED WITH ORAL MEDICATION, DIET, AND EXERCISE. THE ALLEGED ELEVATED READINGS BEGAN (B)(6) 2012. THERE WAS NO ACTION TAKEN IN REGARDS TO HIS DIABETES MANAGEMENT BASED ON THE ALLEGED ISSUE. SUBSEQUENTLY, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "BROKE OUT IN SWEAT, WEAK, AND NAUSEATED" 3.5 MONTHS AFTER THE ONSET OF THE ISSUE. THE PATIENT WAS ABLE TO ADMINISTERED SELF TREATMENT WITH FOOD/DRINK ON (B)(6) 2013, AT 4:20 PM AND TESTED AT 118 MG/DL, ON ANOTHER METER AT 5:17 PM. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THERE WAS NO CONTROL SOLUTION AT THE TIME TO PERFORM A QUALITY TEST. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE INACCURACY ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194013 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening