BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1834298 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07921
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    September 2, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    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

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS BLACK MARKS IN THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION AND A LACK OF THERAPEUTIC RELIEF. THE PATIENT FELT ANTERIOR STIMULATION IN THE TORSO AND CRAMPING AT THE PARESTHESIA SITE. AFTER THE COMPANY REPRESENTATIVE REPROGRAMMING THE PATIENT, THE PATIENT FELT A SHOCKING SENSATION EIGHT TIMES WHILE IN THE RECOVERY ROOM. PATIENT REPORTED THE SURGEON HAD DIFFICULTY PLACING THE LEAD WHICH CAUSED THE IMPLANT SURGERY TO RUN LONG. PATIENT HAD PAIN AT BOTH IMPLANT SITES, WHICH CAUSED HER TO TAKE STRONG PAIN MEDICATION THROUGHOUT THE DAY. THE PATIENT DESCRIBED A LACK OF THERAPEUTIC EFFECT THAT WHEN VOIDING HAD A GREATER QUANTITY BUT UNIMPROVED FREQUENCY. PATIENT WAS SCHEDULED TO SEE HIS DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3017417

    Patients

    Seq Age Sex Outcome Treatment
    1