BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3841976 · Received May 31, 2014

    Report

    Report Number
    2939301-2014-12966
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 23, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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 (07/16/2014) ¿ DEVICE EVALUATION.THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON 06/18/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 07/11/2014, WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. ERROR MESSAGE 3 AND ERROR MESSAGE 4 ARE OBSERVED IN THE ERROR LOG, BUT THE ERRORS WERE NOT REPRODUCED DURING THE INVESTIGATION. 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) 2014, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) USA ON BEHALF OF THE PATIENT, ALLEGING THAT THE ONETOUCH VERIO IQ METER IS GIVING AN ERROR MESSAGE ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ERROR MESSAGE BEGAN APPROXIMATELY 7-10 DAYS AGO. SINCE THE ONSET OF THE REPORTED ISSUE, THE PATIENT REPORTEDLY HAS DECREASED HER NOVOLOG AND LEVIMAR INSULIN TO MANAGE HER DIABETES. THE PATIENT HAD SYMPTOMS DESCRIBED AS ¿NAUSEA AND VOMITING¿ 2 DAYS AFTER THE ISSUE BEGAN. THERE WAS NO REPORT OF ANY REQUIRED HCP TREATMENT TO SUGGEST THE PATIENT HAD ACUTE COMPLICATION OF DIABETES. THE ERROR MESSAGE WAS NOT RESOLVED WITH TRAINING AS THE PATIENT DID NOT HAVE ANY SUPPLIES TO GO TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED ERROR MESSAGE ISSUE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320563 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3330299

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR