BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1901907 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10085
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 3, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/06/2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. 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.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE BLACK MARKS WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    LITERATURE: BRONTE-STEWART H, LOUIE S, BATYA S, HENDERSON JM. CLINICAL MOTOR OUTCOME OF BILATERAL SUBTHALAMIC NUCLEUS DEEP-BRAIN STIMULATION FOR PARKINSON'S DISEASE USING IMAGE-GUIDED FRAMELESS STEREOTAXY. NEUROSURGERY. OCT 2010;67(4):1088-1093; DISCUSSION 1093. SUMMARY: THE AUTHORS REPORTED ON A GROUP OF 20 MEN AND 11 WOMEN WITH PARKINSON'S DISEASE (MEAN AGE OF 62 YRS). TWENTY-EIGHT SUBJECTS HAD BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) AND 3 HAD UNILATERAL STN DBS USING A FRAMELESS APPROACH. THE AUTHORS INDICATED THAT THEIR OUTCOMES RESULTS ARE COMPARABLE TO THOSE REPORTED WITH THE USE OF THE FRAMED-BASED TECHNIQUE. ALL PTS HAD POSTOPERATIVE CT SCANS WITHIN 6 HRS OF THE PROCEDURE; MILD PNEUMOCEPHALUS WAS COMMON, BUT THERE WERE NO INTRACRANIAL HEMORRHAGES. REPORTABLE EVENT: THIS REPORT IS FOR ONE PT WHO DEVELOPED POSTOPERATIVE INFECTIONS REQUIRING DBS LEAD REMOVAL, INTRAVENOUS ANTIBIOTICS, AND SUBSEQUENT REIMPLANTATION. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043978

    Patients

    Seq Age Sex Outcome Treatment
    1