BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2466297 · Received February 23, 2012

    Report

    Report Number
    3008382007-2012-00574
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    February 12, 2012
    Report Date
    February 13, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE 510 (K) # IS K093745.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ON (B)(6) 2012 ALLEGING INACCURATE READINGS WITH HER ONE TOUCH VERIO PRO METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: LAST NIGHT, SHE PERFORMED TWO TESTS AND OBTAINED A 350 MG/DL AND A 210 MG/DL. DUE TO THE DISCREPANCY THE PATIENT CHANGED HER MEDICATION ACCORDING TO THE METER RESULTS. SHE TOOK 24 UNITS BEFORE HAVING DINNER AND TOOK 4 UNITS OF FLEXPEN (AT 4:00 AM) APPROXIMATELY FOUR HOURS LATER, SHE FELL INTO A COMA AND HAD FORTH IN HER MOUTH AND HAD EXCESSIVE PERSPIRATION. THE PATIENT'S HUSBAND FOUND HER AND TREATED HER WITH WATER WITH SUGAR AND A COUPLE OF BISCUITS. AT AN UNSPECIFIED TIME LATER, THE PATIENT HAD REGAINED CONSCIOUSNESS. IT TOOK THE PATIENT MORE THAN 2 HOURS TO COMPLETELY RECOVER. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL AND PARAMEDICS WERE NOT CALLED. DUE TO THE ALLEGED ISSUE, THE PHYSICIAN CONTACTED HER PHYSICIAN AND THE PHYSICIAN CANCELLED HER PRESCRIPTION FOR LEVEMIR 2 UNITS IN THE MORNING. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS SHE TOOK INSULIN BASED ON THE METER READINGS AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HER HUSBAND HAD TO TREAT HER WITH FOOD/DRINK.

    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 3224989

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R