BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3222475 · Received July 12, 2013

    Report

    Report Number
    3008382007-2013-19469
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    July 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 ¿ ((B)(4) 2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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, DURING A FOLLOW-UP CALL, THE LAY USER/PATIENT¿S MOTHER INFORMED LIFESCAN (LFS) THAT THE PATIENT¿S ONETOUCH VERIOIQ METER READ INACCURATELY HIGH ON AT LEAST ONCE OCCASION. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING THE FOLLOW-UP CALL WITH THE REPORTER. THE PATIENT¿S MOTHER REPORTED THAT ON AN UNSPECIFIED DAY IN (B)(6) OF 2013, THE PATIENT OBTAINED AN INACCURATE HIGH RESULT WITH THE SUBJECT METER. THE REPORTER DID NOT KNOW THE ACTUAL READING OBTAINED BUT MENTIONED THE PATIENT TESTED WITHIN HER TYPICAL/NORMAL RANGE WHEN HER BLOOD GLUCOSE MAY HAVE BEEN RUNNING LOWER. THE REPORTER INFORMED THE MSS THAT THE PATIENT IS ON INSULIN PUMP THERAPY. THE PATIENT DID NOT TAKE ANY ACTION IN RESPONSE TO THE RESULT. APPROXIMATELY 1 HOUR AFTER TESTING, THE PATIENT¿S MOTHER STATED THAT THE PATIENT BEGAN TO ACT ¿STRANGELY, IRRATIONAL AND DEVELOPED ANTAGONISTIC BEHAVIOR¿. THE PATIENT¿S FRIEND ATTEMPTED TO TREAT THE PATIENT WITH GLUCOSE; HOWEVER, THE PATIENT WOULD SPIT IT OUT. EMERGENCY SERVICES WAS THEN CONTACTED. WHEN THEY ARRIVED THEY TESTED THE PATIENT¿S BLOOD GLUCOSE AND REPORTEDLY WAS VERY LOW (RESULT NOT KNOWN). THE PATIENT WAS TREATED WITH GLUCOSE. THE REPORTER CLAIMED WHEN SHE ARRIVED TO WHERE THE PATIENT WAS, THE PARAMEDICS RETESTED HER BLOOD GLUCOSE AND IT WAS STILL LOW AT ¿36 MG/DL¿. THE PARAMEDIC¿S INFORMED THE REPORTER THAT THE PATIENT¿S BLOOD GLUCOSE MOST LIKELY HAD DROPPED INTO THE ¿20¿S MG/DL¿. THE PATIENT WAS TREATED WITH ADDITIONAL GLUCOSE UNTIL HER BLOOD GLUCOSE WAS WITHIN HER TARGET RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322341 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR