BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1820460 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07379
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Report Date
    August 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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

    PRODISC-L IMPLANTED FOR DEGENERATIVE DISC DISEASE (B)(6) 2009. PT INVOLVED IN MVA (B)(6) 2009. X-RAY TAKEN (B)(6) 2009, STATUS POST MVA SHOWED PDL ALIGNMENT INTACT WITH NO ABNORMALITIES. POST-OP FILMS TAKEN FOR A ONE YEAR FOLLOW UP SHOWED POLYETHYLENE INLAY HAD DISLODGED. PT EXPERIENCED PAINFUL SYMPTOMS FROM LOWER BACK AND PAIN RADIATING IN LEFT LEG. RIGHT LEG WOULD 'GO TO SLEEP' WHEN LAYING FLAT ON BACK. PT REPORTED ORIGINAL PAIN SYMPTOMS IMPROVED FOR APPROX 6 MONTHS, THEN PAIN RETURNED. MRI TAKEN (B)(6) 2010 SHOWED CONSIDERABLE PARAMAGNETIC ARTIFACT. NO APPRECIABLE CHANGE IN APPEARANCE OF SPINE COMPARED TO PREOP STUDY DONE (B)(6) 2008. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR