BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2480605 · Received March 6, 2012

    Report

    Report Number
    3008382007-2012-00626
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 15, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE 510(K) # IS K110637.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HE WAS UNABLE TO USE HIS ONETOUCH VERIO IQ METER TO PERFORM A TEST BECAUSE IT WAS SHOWING "999 AND HEARTS" ON THE DISPLAY AND THEN IT DID NOT POWER BACK ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(4) 2012, AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, IN THE EVENING AT AN UNKNOWN TIME. HE INFORMED THE MSS THAT HE MANAGES HIS DIABETES WITH A METFORMIN PILL AND GLIPIZIDE PILLS 3-4 TIMES PER DAY AND CHECKS HIS BLOOD GLUCOSE 2-3 TIMES PER DAY; CONTINUED WITH HIS USUAL DIABETES MANAGEMENT ROUTINE. HE STATED THE FOLLOWING DAY, HE WENT TO THE EMERGENCY ROOM (ER) AT APPROXIMATELY 1:30PM IN THE AFTERNOON AFTER THE SUBJECT DEVICE STILL DID NOT POWER ON. HE DENIED DEVELOPING ANY SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA BUT WAS CONCERNED ABOUT NOT TESTING. WHEN HE ARRIVED AT THE EMERGENCY ROOM, HE CLAIMED HIS BLOOD GLUCOSE WAS CHECKED WITH AN HCP METER (BRAND UNKNOWN) AND IT WAS "A LITTLE HIGHER THAN USUAL" BUT HE COULD NOT RECALL THE RESULT. AT APPROXIMATELY 2PM, HE WAS TREATED WITH IV FLUIDS AND RELEASED TWO HOURS LATER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THERE WAS TRAUMA/MISUSE OF THE PRODUCT; THE PATIENT GOT THE METER WET. A REPLACEMENT METER WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY SOUGHT MEDICAL TREATMENT BECAUSE HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND RECEIVED TREATMENT FROM A HEALTH CARE PROFESSIONAL (HCP) FOR CONDITION(S) SUGGESTIVE OF SEVERE HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3248300

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R