BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1801461 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06644
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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

    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

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE RESECTION PROCEDURE, THE TROCAR WAS LEAKING PNEUMO. THE SURGEON PUT SALINE ON THE TOP OF THE TROCAR WHERE THE SEAL CAP IS AND BUBBLING OCCURRED. THEY WERE USING A 5MM GRASPER, BUT THE DEVICE LEAKED WHETHER THERE WAS A DEVICE INSERTED OR NOT. THE CASE WAS COMPLETED WITH THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PATIENT, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN APPROXIMATELY 1 WEEK PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CCA THAT HIS MORNING BLOOD GLUCOSE READINGS ARE USUALLY IN THE "80 MG/DL" RANGE AND EVENING RESULTS ARE USUALLY NO GREATER THAN "180 MG/DL." THE PATIENT CLAIMED HE WAS OBTAINING INACCURATE READINGS IN THE "300 MG/DL" WITH THE SUBJECT METER. ON THE MORNING OF (B)(6) 2010, THE PATIENT CLAIMED HE OBTAINED A RESULT WITH THE SUBJECT METER THAT HE FELT WAS INACCURATELY HIGH (RESULT UNKNOWN). THE PATIENT REPORTED THAT HE NORMALLY ONLY TAKES 50U OF INSULIN AT NIGHT; HOWEVER, IN RESPONSE TO THE ALLEGED HIGH RESULT HE OBTAINED THAT MORNING, THE PATIENT STATED HE TOOK 25U OF 70/30 INSULIN. AT AN UNSPECIFIED TIME, AFTER TAKING THE INSULIN, THE PATIENT CLAIMED HE FELT LIGHTHEADED AND HIS HEART BEGAN TO BEAT FAST. THE PATIENT STATED HE TREATED HIMSELF WITH SUGAR IN RESPONSE TO THE SYMPTOMS AND EVENTUALLY FELT BETTER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE REPORTED PRODUCTS. REPLACEMENT ITEMS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3009678

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R