BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2448121 · Received February 13, 2012

    Report

    Report Number
    3008382007-2012-00392
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 7, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 K093745.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN ON (B)(6) 2012 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH VERIO PRO METER COMPARED TO THEIR ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING THE ANSWERS, SINCE THE PATIENT WAS BUSY ALL WEEK DUE TO A WEDDING AND DID NOT KNOW WHEN WOULD BE A SUITABLE TIME FOR A CALL BACK. THE COMPLAINT WAS CLASSIFIED BASED ON THE INITIAL CALL PLACED ON (B)(6) 2012. WHEN THE PATIENT STARTED USING THE ONE TOUCH VERIO PRO METER, HE NOTICED THE ALLEGED HIGH READINGS ON HIS METER AND STARTED TO COMPARE THE METER TO HIS OLD ONE TOUCH ULTRA METER. THE PATIENT DID NOT RECALL THE RESULTS HE HAD OBTAINED ON BOTH OF THE DEVICES. DUE TO THE DIFFERENCE BETWEEN THE READINGS, HE STOPPED USING THE ONE TOUCH VERIO PRO METER AND STARTED USING THE ACCUCHECK METER. THE PATIENT ALLEGED THAT BECAUSE HE HAD USED HIS VERIO PRO METER HE HAD DEVELOPED 2 SEPARATE HYPOGLYCEMIC EVENTS. HE DID NOT HAVE ANY OF THE RESULTS AVAILABLE FOR THIS EVENT. HE CLAIMED THAT THE FIRST EVENT OCCURRED ON (B)(6) 2011 AT 10:00PM. HE MENTIONED A FEW MINUTES AFTER HIS DINNER, HE NOTICED HIS VISION STARTED TO GET BLURRY (THE ONLY SYMPTOM HE RECALLS HAVING). HE DOES NOT RECALL MUCH OF THE EVENT, ONLY THAT A FEW MOMENT AFTER HE REALIZED THAT HIS WIFE HAD CALLED THE AMBULANCE. PARAMEDICS DID NOT TREAT THE PATIENT WITH ANY MEDICATION. PER PATIENT HIS WIFE MENTIONED THAT THE PARAMEDICS ONLY MONITORED HIS BLOOD GLUCOSE READINGS. NO ADDITIONAL MEDICATION WAS GIVEN TO HIM ON (B)(6) 2012. THEY ONLY ADVISED HIM TO EAT CERTAIN FOODS FOR CERTAIN SITUATIONS. THE SECOND EVENT OCCURRED ON (B)(6) 2012 AT 5:00AM DURING HIS SLEEP. THE PATIENT DOES NOT RECALL EVERYTHING THAT HAD HAPPENED. HE ONLY RECALLS THAT DURING HIS SLEEP HIS WIFE HEARD WEIRD NOISES WITH HIS BREATHING AND THOUGHT IT WAS UNUSUAL. SHE ATTEMPTED TO WAKE HIM UP; HOWEVER, HE WAS HALF CONSCIOUS AND CLAIMS HE AGAIN EXPERIENCED BLURRY VISION. SHE CONTACTED THE PARAMEDICS AGAIN AND SHE MANAGED TO TREAT HIM WITH A SLICE OF BREAD WITH JAM. PARAMEDICS ARRIVED 30 MINUTES LATER, WHILE THE PATIENT WAS EATING AND THEY INJECTED THE PATIENT MEDICATION AND HIS WIFE WAS ADVISED TO ALSO GIVE HIM SOME SWEET WATER. WHEN THE PARAMEDICS LEFT, THE PATIENT WENT BACK TO SLEEP AND WOKE UP APPROXIMATELY 4 HOURS LATER AND HE PERFORMED A TEST AND OBTAINED A RESULT OF 400 MG/DL; HOWEVER, DOES NOT RECALL EXHIBITING ANY SYMPTOMS. HE THEN SELF-TREATED WITH THE USUAL AMOUNT OF FAST ACTING INSULIN HE USUALLY HAD AT THAT TIME (ROUGHLY BETWEEN 9 TO 12 UNITS). SHORTLY LATER HE TESTED AGAIN AND OBTAINED A RESULT OF 130-140 MG/DL . THE PATIENT REFUSED TO GO TO THE HOSPITAL AND FELT THAT THE READINGS WERE "NORMAL." DUE TO THE ISSUES THE PATIENT HAD BEEN EXPERIENCING WITH HIS METER, HIS NURSE DECIDED THAT HE STOP USING THE VERIO PRO METER AND PROVIDED HIM AN ACCUCHECK METER TO USE. VERIO PRO METER WAS REQUESTED BACK FOR INVESTIGATION. ALTHOUGH READINGS WERE NOT PROVIDED ON THE PATIENT'S VERIO PRO METER, THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS HE HAD TAKEN INSULIN AND ON TWO SEPARATE OCCASIONS, DEVELOPED SYMPTOMS AND PARAMEDICS WERE CALLED WHERE HE HAD TO BE TREATED BY PARAMEDICS ON ONE OF THE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3141247

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Life Threatening| R