BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3141855 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14625
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ¿ (09/30/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/12/2013 AND 9/23/2013, RESPECTIVELY, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE ONETOUCH VERIO IQ METER HAS A POWER ISSUE (UNIT POWER OFF DURING USE). THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT¿S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. ACCORDING TO THE REPORTER, THE POWER ISSUE BEGAN ON (B)(6) 2013, AT 4:45 PM. WITHIN THE 10 MINUTES OF THE ONSET OF THE POWER ISSUE, THE PATIENT REPORTEDLY WAS HAVING A DIFFICULTY WITH BREATHING. THE PATIENT CLAIMED HER SYMPTOMS COULD POSSIBLY BE ATTRIBUTED TO HIGH BLOOD GLUCOSE/STRESS. THE PATIENT DID NOT REQUIRE ANY TREATMENT TO SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT WAS EDUCATED ON THE SUBJECT METERS BEHAVIOR AND AUTO-SHUTOFF FEATURE BUT THE ISSUE WAS NOT RESOLVED. THERE WAS PRODUCT MISUSE. BASED ON THE INFORMATION, THE METERS BATTERY DID NOT REQUIRE RECHARGE. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED POWER ISSUE. THERE WAS NO EVIDENCE THE LFS PRODUCT WAS A CONTRIBUTOR OF A SERIOUS INJURY. IN ADDITION, GIVEN THE SHORT TIME (10 MINUTES) BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE REPORTED SYMPTOMS, THE PATIENT LIKELY FELT SYMPTOMATIC PRIOR TO OR WHEN THE ISSUE BEGAN. THEREFORE THE METER DID NOT CONTRIBUTE TO THE PATIENT¿S SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244994 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR