BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1843230 · Received September 24, 2010

    Report

    Report Number
    2939301-2010-08391
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Report Date
    September 17, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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

    (B)(4). 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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER POWERS OFF DURING USE. 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

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A PHARMACY, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNKNOWN AGE, GENDER, OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2010, THE HUMAPEN MEMOIR BURGUNDY PEN WAS REPORTED TO HAVE DIGITS ON THE DISPLAY THAT WERE NOT COMPLETE. THIS HUMAPEN MEMOIR BURGUNDY PEN WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0910C02. THE RETURNED DEVICE WAS FOUND TO HAVE PART OF THE STRIPE IN THE DOSE DISPLAY DIGITS MISSING. THE OPERATOR OF THE DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE USER WAS TRAINED. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME. THE DEVICE WAS RETURNED ON 07-OCT-2010. THE HUMAPEN MEMOIR BURGUNDY PEN WAS NOT CONTINUED. UPDATE 29-OCT-2010: ADDITIONAL INFORMATION RECEIVED ON 27-OCT-2010 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; UPDATED THE EU/CA FIELDS AND THE NARRATIVE.

    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