BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 3242476 · Received July 23, 2013

    Report

    Report Number
    3008382007-2013-20813
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    FOLLOW-UP # 1 ¿ (11/19/2013) THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING A ONETOUCH SELECT SIMPLE METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HIS FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED 2 MONTHS PRIOR TO CONTACTING LFS. THE PATIENT ALLEGED OBTAINING READINGS OF ¿200-242MG/DL¿ ON THE LFS METER COMPARED HIS FEELINGS. THE PATIENT REPORTED HIS NORMAL READINGS ARE ABOUT ¿165MG/DL.¿ THE PATIENT REPORTED IN RESPONSE TO THE INCREASED BLOOD GLUCOSE READINGS, HE CONTACTED HIS DOCTOR FOR ADVISE, AND HE WAS TOLD TO SWITCH FROM ¿GLUCO NORM G1¿ TO ¿GLUCO NORM G2.¿ THE PATIENT REPORTED SOME TIME LATER HE DEVELOPED SYMPTOMS OF ¿SWEATING AND FEELING WEAK.¿ THE PATIENT REPORTED HE CONTACTED HIS DOCTOR AGAIN AND WAS TOLD TO DISCONTINUE THE NEW MEDICATION AND TO GO BACK TO ¿GLUCO NORM G1.¿ THE PATIENT REPORTED HIS BLOOD GLUCOSE WAS NOT MEASURED USING ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344090 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R