BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2243440 · Received September 12, 2011

    Report

    Report Number
    2939301-2011-08849
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    March 25, 2011
    Report Date
    September 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 510 (K) # IS K082513.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS HE RECEIVED ON HIS ONE TOUCH VITA METER ON (B)(6) 2011. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, WHEN THE CUSTOMER CARE ADVOCATE (CCA) ATTEMPTED TO CONTACT THE PATIENT, HOWEVER THE PATIENT REFUSED TO ANSWER ANY ADDITIONAL QUESTIONS AND CLAIMED HE DOESN'T REMEMBER ANY INFORMATION ABOUT THE INCIDENT ON (B)(6) 2011. THE COMPLAINT IS BEING CLASSIFIED BASED ON THE INITIAL CALL PLACED TO LFS ON (B)(6) 2011. THE PATIENT MENTIONED ON (B)(6) 2011 HE WAS VERY SCARED WHEN HE EXHIBITED SYMPTOMS OF HYPOGLYCEMIA. HE CLAIMED THAT THERE WAS A HUGE DIFFERENCE BETWEEN THE READINGS ON HIS METER. BASED ON THE INITIAL CALL IT WAS STATED THAT THE PATIENT HAD OBTAINED A 580 MG/DL AND A 60 MG/DL ON THE LFS METER ON (B)(6) 2011. THE PATIENT HAD DEVELOPED SYMPTOMS OF FAST HEARTBEAT AND BREATHING PROBLEMS; HOWEVER, IT IS UNKNOWN WHETHER THE PATIENT HAD DEVELOPED THE SYMPTOMS BEFORE OR AFTER TESTING ON THEIR LFS METER. IT IS ALSO UNCLEAR WHETHER THE PATIENT EXHIBITED ANY OTHER SYMPTOMS. READINGS WERE TAKEN WITHIN 20 MINUTES FROM ONE ANOTHER. THE PATIENT TOOK HIS USUAL DOSAGE OF DIABETES MEDICATION (INSULIN). AT AN UNSPECIFIED TIME AFTER TESTING ON THE LFS METER, THE PATIENT CONTACTED EMS AND WAS TESTED ON THE EMS METER AND OBTAINED A 10 MG/DL AND WAS TREATED; HOWEVER, THERE IS NO INFORMATION WAS TREATMENT THE PATIENT RECEIVED OR WHETHER THE PATIENT WAS TAKEN TO THE HOSPITAL. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE EVENT. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, WHETHER THE SYMPTOMS OCCURRED BEFORE OR AFTER TESTING, WHAT THE PATIENT WAS TREATED WITH AND WHETHER HIS DIABETES MEDICATION WAS CHANGED DUE TO THE ALLEGED ISSUE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PATIENT ASSUMED THAT THE ISSUE COULD BE CAUSED BY THE FRICTION OF THE STRIPS IN THE BOX OF 25 TEST STRIPS THAT COULD BE THE CAUSE OF THE INACCURACY. THE CUSTOMER CARE ADVOCATE (CCA) INFORMED THE PATIENT THAT THE TEST STRIPS COULD NOT BE WRAPPED INDIVIDUALLY IN THE VIAL. PATIENT WAS NOT CONVINCED AND FELT THAT THE TEST STRIPS SHOULD BE WRAPPED INDIVIDUALLY. THE PRODUCT WAS REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT OBTAINED ERRATIC READINGS ON HIS METER, HAD TAKEN HIS USUAL DOSAGE OF MEDICATION AND LATER HAD TO BE TREATED BY PARAMEDICS FOR A BLOOD GLUCOSE READING OF 10 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3164258

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R