BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY

    MDR report key: 1885591 · Received October 28, 2010

    Report

    Report Number
    2939301-2010-09553
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 24, 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.THE 510K #K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/08/2010. 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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 1/05/2011: 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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING THAT THE ONETOUCH ULTRAEASY METER IS GIVING INACCURATE ERRATIC READINGS. THIS MEDICAL SURVEILLANCE SPECIALIST OBTAINED FOLLOW UP INFORMATION ON OCTOBER 27, 2010. THE PATIENT MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN BASED ON THE LFS METER READINGS. SHE TESTS 6 TIMES PER DAY AND SOMETIMES MORE IF THERE IS ANY SYMPTOMS. HER LENTUS INSULIN INTAKE RANGES FROM 12-14 UNITS WHILE HER APIDRA INSULIN RANGES FROM 14 TO 26 UNITS. ON (B)(6) 2010, THE PATIENT TESTED ON THE SUBJECT METER AND OBTAINED READINGS OF "92, 70, 69, AND 157 MG/DL' AND "204, 176, 74, 170, 165, 122, AND 42 MG/DL" RESPECTIVELY. THE ALLEGED INACCURATE READINGS WERE TAKEN BEFORE AND AFTER EACH MEAL AND DURING THE NIGHT. THE PATIENT CLAIMED THAT SHE ADJUSTED HER INSULIN ACCORDING TO THE LFS METER READINGS AND SUBSEQUENTLY DEVELOPED HYPOGLYCEMIC SYMPTOMS DESCRIBED AS "SHAKING, SWEATING, AND VISION TROUBLES" ON BOTH DAYS. THERE WAS NO ALLEGATION OF MEDICAL INTERVENTION FOR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA DUE THE ALLEGED ISSUE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, ALL READINGS WERE PERFORMED 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 REPORTEDLY, DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE LFS METER READINGS.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 14 YEARS AND 11 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL REGURGITATION. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS IDENTIFIED AS HAVING PROGRESSION OF HER MITRAL REGURGITATION NOW AFFECTING THE AORTIC VALVE AND THE TRICUSPID VALVE. THUS, SHE WAS RECOMMENDED FOR MVR. PER THE SURGEON, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A PRODUCT MALFUNCTION, BUT RELATED TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A PERFUSION SET WHERE AIR BUBBLES WERE OBSERVED. NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS EVENT OCCURRED DURING PRIMING. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening