BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1880754 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09373
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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. THE 510K # K062195.

    Description of Event or Problem · 1

    REFERENCE: MDR 1220063-2010-00040. PER TELEPHONE COMMUNICATION WITH DRAEGER MEDICAL REGARDING THE SUBMITTAL OF ADDITIONAL MDRS FOR EACH SERIAL NUMBER LISTED ON THE INITIAL MDR SUBMITTED, DRAEGER IS SUBMITTING THIS REPORT. IT WAS REPORTED THAT THE DISPLAY OF THE INFINITY DELTA PRESENTS ALEATORY DISFUNCTIONS. IT WAS ALSO REPORTED THAT ONCE THE MONITOR IS RUNNING, THE "MENU" AND "STAND BY" WINDOW SUDDENLY APPEAR AND THERE IS NO WAY TO GET OUT OF IT BY PRESSING ANY OTHER KEY UNTIL IT DISAPPEARS BY ITSELF. THERE ARE NO ERRORS FOUND (IN THE ERROR LIST) THAT COULD BE ASSOCIATED TO THIS IRREGULARITY PRESENT BY THE EQUIPMENT. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® ULTRA METER HAD A CALCODE ISSUE AND SUBSEQUENTLY DID NOT POWER ON. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION. ON (B)(6) 2010 AT 11:30 PM, THE PATIENT REPORTEDLY COULD NOT CODE THE METER BECAUSE SHE DID NOT HAVE ANY TEST STRIPS. IN ADDITION, THE SUBJECT METER WOULD NOT POWER ON. SHE REPORTEDLY COULD NOT OBTAIN HER BLOOD GLUCOSE READING AT THE TIME OF CONCERN. ACCORDING TO THE PATIENT, SHE INCREASED HIS ORAL MEDICATION DUE TO THE ALLEGED ISSUE. AROUND 5:30 AM, THE PATIENT DEVELOPED SYMPTOM DESCRIBED AS "PERSPIRATION" AND ADMINISTERED SELF TREATMENT WITH FOOD AND/OR DRINK. THE PATIENT DID NOT TEST ON ANY OTHER DEVICE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE SUBJECT METER POWERS ON WITH THE POWER BUTTON. HOWEVER, THE POWER ISSUE AND CALCODE ISSUE WAS NOT RESOLVE SINCE THE PATIENT DID NOT HAVE ANY TEST STRIPS TO CONTINUE WITH THE TROUBLESHOOTING PROCESS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE PATIENT COULD NOT TEST ON THE SUBJECT METER DUE TO THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2942377

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R