BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 3429218 · Received October 25, 2013

    Report

    Report Number
    2939301-2013-06388
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    October 12, 2013
    Report Date
    October 21, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082513
    Adverse Event
    Yes
    Product Problem
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VITA METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT ON (B)(6) 2013, AT 7AM, HE OBTAINED BLOOD GLUCOSE READINGS OF ¿122 MG/DL¿ WITH THE SUBJECT METER AND ¿109 MG/DL¿ ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT INFORMED THE CSR THAT HE TESTS HIS BLOOD GLUCOSE 2X/DAY AND WAS TAKING ORAL MEDICATION (METFORMIN) TO MANAGE HIS DIABETES. DURING THE FOLLOW-UP CALL, THE PATIENT INFORMED THE CSR THAT NORMAL/TYPICAL BLOOD GLUCOSE READINGS FOR HIM RANGE FROM ¿140 TO 150 MG/DL¿. PRIOR TO THE METER TO LAB COMPARISON, THE PATIENT CONFIRMED HIS BLOOD GLUCOSE READINGS WERE RUNNING ¿BELOW NORMAL¿. IT IS NOT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE METER RESULTS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF FEELING ¿SWEATY, COLD AND HAD TO EAT¿ AT AN UNSPECIFIED TIME ON (B)(6) 2013. THE PATIENT DID NOT RECALL WHEN HE HAD LAST TESTED WITH THE SUBJECT METER PRIOR TO ONSET OF SYMPTOMS NOR DID HE RECALL WHAT READING HE OBTAINED. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED HE ATE FOOD AND SCHEDULED AN APPOINTMENT WITH HIS HCP. THE PATIENT REPORTED THAT HE SAW HIS HCP ON (B)(6) 2013. THE PATIENT STATED THAT DURING DOCTOR¿S OFFICE VISIT, HIS HCP TOLD HIM TO STOP TAKING HIS ORAL MEDICATION. AT THE TIME OF TROUBLESHOOTING, THE PATIENT PERFORMED A CONTROL SOLUTION TEST AND IT WAS NOTED THAT THE RESULT FELL OUTSIDE OF THE SPECIFIED CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER HE BEGAN TO OBTAIN ALLEGED INACCURATE HIGH BLOOD GLUCOSE RESULTS WITH THE LFS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548119 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3468444

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R