BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1882027 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09419
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 11/19/2010: THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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 510K #K053529 U2.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR SALES STAFF THAT HE RECEIVED A CALL FROM THE HOSPITAL CONTACT REGARDING AN EXPLANT, NO ADDITIONAL INFORMATION WAS GIVEN OTHER THAN A RETURN KIT WAS REQUESTED. ON 17-NOV-2010, A COPY OF A VOLUNTARY MEDWATCH UF/IMPORTER REPORT# (B)(4) WAS RECEIVED. IT REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A REDO STERNOTOMY, EXPLANTATION OF A 21MM EDWARDS BOVINE PERICARDIAL TISSUE HEART VALVE, AORTIC VALVE REPLACEMENT WITH A 23MM SORIN MITROFLOW BOVINE PERICARDIAL TISSUE HEART VALVE, AND TRICUSPID VALVE REPAIR WITH A 32MM MC3 ANNULOPLASTY BAND SECONDARY TO PROSTHETIC VALVE STENOSIS WITH PERIVALVULAR REGURGITATION AND CONGESTIVE HEART FAILURE CLASS 3. THIS AORTIC VALVE HAD BEEN PLACED IN (B)(6) 2003 BY DR (B)(6).

    Description of Event or Problem · 1

    THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING INACCURATE ERRATIC READINGS OF "127, 100, 150 MG/DL." ON OCTOBER 25, 2010, THIS MEDICAL SURVEILLANCE SPECIALIST OBTAINED FOLLOW UP INFORMATION FROM THE PATIENT. THE PATIENT TESTS HER BLOOD GLUCOSE 4 TIMES PER DAY AND MANAGES HER DIABETES WITH LANTUS AND HUMALOG INSULIN. THE PATIENT TAKES A SET AMOUNT OF LANTUS EACH DAY WHILE HER HUMALOG INSULIN IS BASED ON A SLIDING SCALE REGIMEN. ACCORDING TO THE PATIENT, ON THE NIGHT OF (B)(6) 2010, SHE OBTAINED A BLOOD GLUCOSE READING OF "150 MG/DL" ON THE SUBJECT METER AND TOOK HER USUAL LANTUS INSULIN. THE NEXT DAY AT 10 AM, SHE OBTAINED READINGS OF "127, 100, AND 150 MG/DL" WHICH THE PATIENT FELT WAS INACCURATELY HIGH COMPARED TO HER NORMAL READINGS RANGING FROM "94-102 MG/DL." THE PATIENT ATE HER BREAKFAST AND TOOK HER HUMALOG INSULIN PER HER SLIDING SCALE REGIMEN BASED ON THE ALLEGED "150 MG/DL." THE PATIENT WENT TO RUN SOME ERRANDS AND REPORTEDLY DEVELOPED SYMPTOMS OF "CONSTANT SWEATING, ANXIOUSNESS, AND HEART PALPITATION¿ AT 11 AM. SHE TESTED AT "60 MG/DL" ON THE SUBJECT METER AND PROMPTLY ADMINISTERED SELF TREATMENT WITH ORANGE JUICE. HER SYMPTOMS ABATED SHORTLY AFTER THE TREATMENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE REPORTED METER READINGS OF "127, 100, AND 150 MG/DL" WERE TAKEN MORE THAN 20 MINUTES OF EACH OTHER. TO COMPARE METER TO SAME METER RESULTS, THE READINGS SHOULD BE TAKEN WITHIN 20 MINUTES PER LIFESCAN'S CRITERIA FOR PRECISION TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE LFS METER READING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF MULTIPLE INSTANCES OF NO FLOW, EXACT AMOUNT UNKNOWN. THE SETS WOULD NOT PRIME. THIS INCIDENT OCCURRED WITH THE INTERLINK CONTINU-FLO SOLUTION SET. THE CUSTOMER ADMITTED THAT THEY DID NOT INVERT AND TAP THE CHECK VALVE PER LABEL COPY. WHEN INVERTING AND TAPPING THE CHECK VALVE THE SETS WOULD FLOW FINE. THE CUSTOMER ALSO ADMITTED THAT THEY DID NOT READ THE LABEL COPY WHEN PRIMING THE SETS. THIS INCIDENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3040721

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R