BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 4123953 · Received September 27, 2014

    Report

    Report Number
    2939301-2014-25675
    Event Type
    Injury
    Date Received
    September 27, 2014
    Report Date
    September 25, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THEIR ONETOUCH VERIOPRO METER READ INACCURATELY HIGH COMPARED TO THEIR NORMAL READINGS AND ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THREE WEEKS PRIOR TO CONTACTING LFS (DATE NOT PROVIDED), HE TESTED HIS BLOOD GLUCOSE 1 HOUR AFTER DINNER AND OBTAINED AN ELEVATED RESULT OF ¿180 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MENTIONED NORMAL RESULTS FOR HIM ARE BETWEEN ¿90 ¿ 100 MG/DL.¿ THE PATIENT MANAGES HIS DIABETES WITH LEVEMIR (TWICE A DAY) AND HUMALOG INSULIN (BASED ON BLOOD GLUCOSE READING). THE PATIENT INFORMED THE CSR THAT HE ONLY ADMINISTERS THE HUMALOG INSULIN IF HIS BLOOD GLUCOSE IS GREATER THAN 150 MG/DL. IN RESPONSE TO THE ALLEGED HIGH RESULT, THE PATIENT REPORTED THAT HE ADMINISTERED 1 UNIT OF HUMALOG INSULIN AND THEN LAID DOWN. APPROXIMATELY 1 HOUR LATER, THE PATIENT¿S SPOUSE REPORTEDLY CHECKED IN ON HIM AND SAW THAT HE DID NOT LOOK WELL. THE PATIENT MENTIONED HE WAS FEELING ¿UNEASY¿ AND ¿TALKING CONFUSED¿. IN RESPONSE TO PATIENT¿S SYMPTOMS, THE PATIENT STATED HIS SPOUSE GAVE HIM A SMALL GLASS OF GRAPE JUICE; HOWEVER, WHEN HE STILL WAS NOT FEELING BETTER AFTER 20 MINUTES, SHE CONTACTED THE PARAMEDICS. THE PATIENT REPORTED THAT WHEN THE PARAMEDICS ARRIVED THEY ADMINISTERED A GLUCAGON INJECTION AND TOOK HIM TO THE HOSPITAL. IT IS NOT KNOWN IF THE PARAMEDICS TESTED THE PATIENT¿S BLOOD GLUCOSE PRIOR TO ADMINISTERING THE GLUCAGON INJECTION. UPON ARRIVAL TO THE HOSPITAL, THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE WAS TESTED WITH A HOSPITAL METER AND THE RESULT WAS ¿126 MG/DL.¿ THE PATIENT INFORMED THE CSR THAT WITHIN 30 MINUTES OF THE TEST WITH HOSPITAL METER, HIS BLOOD GLUCOSE WAS ALSO TESTED WITH THE SUBJECT METER AND THE RESULT OBTAINED WAS ¿180 MG/DL.¿ BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LFS¿ ACCURACY CRITERIA. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE TESTING SUPPLIES WITH HIM; HOWEVER, CLAIMED THAT THE TEST STRIPS HE WAS USING AT TIME HE OBTAINED INACCURATE HIGH RESULTS WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603909 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R