BEUDAMED
    FDA Adverse Event Summary report: N

    OT VERIO2 METER

    MDR report key: 5040612 · Received August 29, 2015

    Report

    Report Number
    2939301-2015-36510
    Date Received
    August 29, 2015
    Date of Event
    August 23, 2015
    Report Date
    August 24, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2: DEVICE EVALUATION. THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH VERIO 2 METER WAS READING INACCURATELY HIGH COMPARED TO FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT DETAILED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2015; 18:00 - 18:30. SHE REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE RESULT OF 177MG/DL ON THE SUBJECT METER WHICH SHE WAS COMPARING TO HISTORIC RESULTS FROM A LOG BOOK WHICH SHE HAD RECORDED WITH A PREVIOUS METER. THE PATIENT MANAGES HER DIABETES BY SELF-ADJUSTING THEIR INSULIN DOSAGE AND REPORTED THAT ON "(B)(6) 2015; 18:00 - 18:" SHE INCREASED HER DOSE OF MEDICATION "7 UNITS OF HUMALOG" AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT "2 -.5 HOURS" FTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED THE SYMPTOMS OF "SHAKY AND RACING HEART", WHICH SHE SELF-TREATED WITH "LIQUID DEXTROSE." AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE PATIENT NO LONGER HAD CONTROL SOLUTION TO CARRY OUT A TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573296 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3783099

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening