BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4642916 · Received March 31, 2015

    Report

    Report Number
    2939301-2015-12575
    Event Type
    Injury
    Date Received
    March 31, 2015
    Report Date
    March 17, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION - (B)(6) 2015. THE CUSTOMER CARE ADVOCATE WAS ABLE TO CONTACT THE PATIENT WITH QUESTIONS FROM THE MEDICAL SURVEILLANCE SPECIALIST ON (B)(6) 2015. THE FOLLOWING CORRECTED INFORMATION WAS OBTAINED. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON (B)(6) 2015. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿224, 201, 197, 209 AND 217 MG/DL¿ ON THE SUBJECT METER; HOWEVER THE TIME AT WHICH THESE RESULTS WERE OBTAINED IS UNKNOWN. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT REPORTED CONTINUING TO TAKE THEIR USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE; HOWEVER REPORTED OBTAINING BLOOD GLUCOSE READINGS ON A LABORATORY DEVICE OF ¿OVER 500 AND WENT UP OVER 700 MG/DL¿. THE PATIENT COULD NOT RECALL WHEN THESE RESULTS WERE OBTAINED. THE PATIENT DID NOT REPORT ANY MEDICAL TREATMENT FROM THEIR HCP. AT THE TIME OF TROUBLESHOOTING THE CCA VERIFIED THAT THE UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MAY HAVE SUFFERED A SERIOUS BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    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 -(B)(6) 2015 DEVICE EVALUATION. THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 3/30/2015 AND 3/30/2015, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 4/1/2015 AND 4/10/2015 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS 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) 2015 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE CUSTOMER CARE ADVOCATE (CCA) ATTEMPTED TO CONTACT THE PATIENT WITH QUESTIONS FROM THE MEDICAL SURVEILLANCE SPECIALIST BUT WAS UNABLE TO REACH THE PATIENT. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE ORIGINAL CCA DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON (B)(6) 2015. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿224, 201, 197, 209 AND 217 MG/DL¿ ON THE SUBJECT METER; HOWEVER THE TIME AT WHICH THESE RESULTS WERE OBTAINED IS UNKNOWN. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT REPORTED INCREASING THEIR USUAL DOSE OF GLIMEPIRIDE TO TWO TABLETS A DAY IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE; HOWEVER REPORTED OBTAINING BLOOD GLUCOSE READINGS ON A LABORATORY DEVICE OF ¿OVER 500 AND WENT UP OVER 700 MG/DL¿ ON (B)(6). THE PATIENT REPORTED RECEIVING HCP TREATMENT OF ¿GLUCOSE TABLETS/GEL¿ ON THE SAME DAY. AS WE WERE UNABLE TO REACH THE PATIENT IS IT UNKNOWN IF THE PATIENT SUFFERED AN INJURY OF HYPERGLYCEMIA OR HYPOGLYCEMIA. AT THE TIME OF TROUBLESHOOTING THE CCA VERIFIED THAT THE UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MAY HAVE SUFFERED A SERIOUS BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213246 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3651472

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R