BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1885622 · Received October 28, 2010

    Report

    Report Number
    2939301-2010-09554
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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

    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

    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.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON OCTOBER 11, 2010 ALLEGING THAT THE ONETOUCH® ULTRA2 METER IS GIVING INACCURATE ERRATIC READINGS OF "228 AND 199 MG/DL" ON THE SUBJECT METER. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. BASED ON THE REPORTED METER READINGS OBTAINED ON THE SUBJECT METER, THE PATIENT REPORTEDLY ALTERED HER DIABETES MANAGEMENT BY TAKING LESS FOOD/DRINK ON (B)(6) 2010 IN THE "PM" TIME FRAME. AT 3 HOURS LATER, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS DESCRIBED AS "SHAKING AND SWEATING.' THERE WAS NO ALLEGATION OF TREATMENT FOR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA AT THE TIME OF CONCERN. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE REPORTED METER READINGS OF "228 AND 199 MG/DL" WERE PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS IS WITHIN THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER HER DIABETES MANAGEMENT WAS ALTERED PER THE ALLEGED LFS METER READINGS.

    Description of Event or Problem · 1

    CLIP JAMMED IN THE END OF THE DEVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE AMI CUT OFF, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS' SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LAB. UPON REPEAT ON A DIFFERENT INSTRUMENT THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3030457

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening