BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3093555 · Received May 6, 2013

    Report

    Report Number
    3008382007-2013-10231
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 9, 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 ¿ (07/29/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/9/2013 AND 7/24/2013, 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/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIO IQ METER POWERS OFF DURING USE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013 (BETWEEN 1-1:30PM) AFTER OBTAINING AN EXTREME HIGH GLUCOSE MESSAGE SEVERAL TIMES AFTER LUNCH. THE PATIENT REPORTEDLY WAS AWARE THAT HER BLOOD GLUCOSE HAS THE TENDENCY TO BE ELEVATED. AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTEDLY TESTED WITH A SECONDARY DEVICE (BAYER) AND OBTAINED AN EXTREME HIGH MESSAGE. THE PATIENT MANAGES HER DIABETES WITH 2500MG OF METFORMIN THREE TIMES A DAY, 10ML/DAY OF "TRAJET", 80 UNITS OF LANTUS (MORNING AND EVENING), AND NOVARAPID (SLIDING SCALE). PER CSR NOTES, THE PATIENT ADMINISTERED AN UNSPECIFIED DOSE OF NOVARAPID INSULIN AFTER LUNCH, WHEN SHE NOTICED HER BLOOD GLUCOSE READINGS WERE NOT DECLINING AFTER TREATMENT, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (E.R.) AT APPROXIMATELY 2PM. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ALLEGED METER ISSUE. DURING THE PATIENT'S TIME IN THE ER, THE PATIENT REPORTEDLY OBTAINED A READING OF "62MMOL/L" WITH THE HOSPITAL'S METER; SHE WAS ADMINISTERED (BY THE HEALTH CARE PROFESSIONAL; HCP) 80 UNITS OF NOVARAPID INSULIN AS TREATMENT; 15 MINUTES LATER THE PATIENT WAS RETESTED WITH THE HOSPITAL'S METER ("29MMOL/L"); AGAIN WAS ADMINISTERED 80 UNITS OF NOVARAPID; 20 MINUTES LATER AN ADDITIONAL 80 MORE UNITS WAS ADMINISTERED; AND AT AN UNKNOWN TIME LATER THE PATIENT'S BLOOD GLUCOSE "WENT DOWN INTO THE TEENS" (HER NORMAL RANGE). THE PATIENT WAS SOON AFTER DISCHARGED FROM THE E.R. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THE METER'S BATTERY DID NOT NEED TO BE RECHARGED, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. HE ALLEGED METER ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196903 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR