BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 6253011 · Received January 16, 2017

    Report

    Report Number
    3008382007-2017-02295
    Event Type
    Injury
    Date Received
    January 16, 2017
    Report Date
    January 6, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH SELECT SIMPLE METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT BETWEEN (B)(6) 2016 AND (B)(6) 2016, THE PATIENT OBTAINED ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿100, 120, 280, 119, 210, 130, 200, 150, 300, 145, 250 AND 130 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 REPORTER INFORMED THE CSR THAT AT THE TIME OF THE ALLEGED ISSUE THE PATIENT MANAGED HIS DIABETES WITH HUMAN MIXTARD INSULIN. IN RESPONSE TO THE ELEVATED RESULTS, THE REPORTER CLAIMED THE PATIENT INCREASED HIS DOSE OF INSULIN. THE REPORTER STATED THAT 2 DAYS AFTER THE ALLEGED ISSUE BEGAN THE PATIENT ¿VOMITED AND FELT HUNGRY¿; SYMPTOMS HE REPORTEDLY EXPERIENCES WITH AN UNDERLYING HEALTH CONDITION. THE REPORTER CLAIMED THAT ON (B)(6) 2016, SIX DAYS AFTER THE ALLEGED ISSUE STARTED, THE PATIENT SKIPPED LUNCH IN RESPONSE TO AN ALLEGED INACCURATE RESULT OF ¿130 MG/DL¿ WITH THE SUBJECT METER. THE REPORTER CLAIMED THAT LATER THAT EVENING THE PATIENT EXPERIENCED SYMPTOMS OF ¿TIREDNESS, UNEASINESS AND DIFFICULTY SPEAKING¿. IN RESPONSE TO THE SYMPTOMS, THE REPORTER STATED THE PATIENT WAS IMMEDIATELY TAKEN TO HOSPITAL WHERE HE RECEIVED TREATMENT OF IV GLUCOSE. THE REPORTER STATED THE PATIENT¿S BLOOD GLUCOSE WAS TESTED ON ANOTHER DEVICE (ACCU-CHEK) ON THE EVENING OF (B)(6) 2016 AND A RESULT OF ¿39 MG/DL¿ WAS OBTAINED¿. THE REPORTER CLAIMED THE PATIENT WAS HOSPITALIZED FOR 20 DAYS AND THAT HIS INSULIN WAS CHANGED TO NOVORAPID ON DISCHARGE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. THE PRODUCTS INVOLVED IN THE COMPLAINT WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOM THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT THE ALLEGED INACCURACY ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36102 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R