BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1912054 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10397
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    May 9, 2010
    Report Date
    November 23, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 510(K) # IS K082513.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM (INDICATING AIR IN THE SET) THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 3 OF 4. GTS HAD THE HP DISCONNECT AND REMOVE THE CASSETTE FROM THE MACHINE TO DISCARD THE SUPPLIES. GTS ADVISED THE HP TO CONTACT THE NURSE ABOUT MISSED THERAPY. DURING THERAPY, THE HP PROVIDED THE LOT NUMBER AND SAID SHE RESUMED THERAPY FINE AFTER THE ALARM. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER SPOKE WITH THE HOME PATIENT (HP) ON (B)(6) 2010 REGARDING THE REPORTED PROBLEM. THE HP SAID THAT SHE DID NOT KNOW HOW THE AIR MAY HAVE GOTTEN IN THE LINE. SHE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. SHE SAID THAT SHE RESUMED THERAPY "FINE." THE HP DID NOT NOTIFY HER NURSE, AND THE WRITER ADVISED ANY TIME THERE IS AIR IN THE LINE, WE WOULD ADVISE TO CONTACT THE NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION FOR ADDITIONAL FOLLOW UP QUESTIONS ON (B)(6) 2010. THE PATIENT INFORMED THE CCA THAT HIS TESTING FREQUENCY IS 3 TIMES PER DAY AND MANAGES HIS DIABETES WITH ORAL MEDICATIONS (METFORMIN 500MG & GLIMEPIRIDE). THE PATIENT CONFIRMED THE ALLEGED ISSUE BEGAN ON THE MORNING OF MAY 9, 2010 AT 7:56AM WITH A READING OF "213 MG/DL" WITH THE SUBJECT METER. THE OTHER READINGS OBTAINED IN THE MONTH OF (B)(6) 2010 WERE "148, 130, 123, 129, 130, 130, 142, 116, 131, 117, 108, 177 AND 87 MG/DL" WHICH THE PATIENT INDICATED ARE NOT WITHIN HIS NORMAL BLOOD GLUCOSE READINGS OF "110-115 MG/DL" IN THE EARLY MORNING BEFORE EATING BREAKFAST. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT STATED HE CONTINUED TAKING HIS USUAL DOSE OF MEDICATION. AT AN UNSPECIFIED TIME IN (B)(6) 2010, THE PATIENT STATED HE LOST CONSCIOUSNESS (WHICH HE ASSOCIATED AS HYPOGLYCEMIA) SEVERAL TIMES THAT HE WAS HOSPITALIZED; HOWEVER IT IS NOT KNOWN WHAT TREATMENT HE RECEIVED OR WHAT BLOOD GLUCOSE READINGS WERE OBTAINED AT THE TIME HE WAS HOSPITALIZED. WITH AN UNKNOWN BLOOD GLUCOSE READING OR SYMPTOMS, THE PATIENT CLAIMED ON (B)(6) 2010 HE WAS HOSPITALIZED AGAIN AND RECALLS BEING ADMINISTERED 4 UNITS OF INSULIN. AFTER THE TREATMENT, THE PATIENT INDICATED HE WAS FEELING BETTER AFTERWARDS. THE PATIENT INDICATED FROM (B)(6) 2010, HE RECALLS BEING TESTED BY THE HOSPITAL METER AND OBTAINING READINGS OF "110-115 MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3003400

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening