BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 6201732 · Received December 23, 2016

    Report

    Report Number
    3008382007-2016-65757
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    September 18, 2016
    Report Date
    December 6, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008136
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2016. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2016 AT AROUND 6:00 AM. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿202, 191, 186, 192, 92, 204 AND 281 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH HUMALOG AND LANTUS INSULIN AND SELF-ADJUSTS THE DOSE BASED ON A SLIDING SCALE. THE PATIENT INFORMED THAT MSS THAT HE TOOK AN INCREASED DOSE OF 7 UNITS OF HUMALOG INSULIN ON (B)(6) 2016 AT AROUND 6:30 OR 7:00 AM IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AROUND ONE HOUR LATER HE DEVELOPED SYMPTOMS OF ¿RINGING IN EARS AND FEELING SHAKY¿. DURING THE FOLLOW-UP CALL, THE PATIENT WAS UNABLE TO CONFIRM IF HE ASSOCIATED THE SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE OR IF HE RECEIVED ANY TREATMENT FOR THE SYMPTOMS. DURING TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR CONFIRMED THAT THE TEST STRIPS WERE STORED CORRECT AND WERE NOT EXPIRED OR PAST THEIR DISCARD DATE. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852448 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3901391 00353885008136

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening