BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2392065 · Received December 29, 2011

    Report

    Report Number
    2939301-2011-12927
    Event Type
    Injury
    Date Received
    December 29, 2011
    Report Date
    December 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/10/2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PIN LIFTED HIGH. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    510(K) # IS K080639. 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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN REPORTING AN "ERROR 4" ISSUE WITH THE SUBJECT METER. THE REPORTED ISSUE FIRST OCCURRED ON (B)(6) 2011 AFTERNOON. THE PATIENT REPORTEDLY STARTED TO HAVE FLUCTUATING SYMPTOMS OF HIGH (IRRITABILITY, CONFUSION, INCOHERENCE) AND LOW (SHAKY) BLOOD GLUCOSE THE FOLLOWING MORNING AT 11AM. THE PATIENT DID NOT MAKE ANY CHANGES TO HIS BASAL RATE OF INSULIN ON HIS INSULIN PUMP DURING THIS TIME; HOWEVER, NOTED THAT HE WAS ABLE TO TEST ON (B)(6) 2011 ON A BACKUP METER AND OBTAINED A "228 MG/DL" SO HE TOOK 2 UNITS OF INSULIN. NO OTHER FORMS OF MEDICAL INTERVENTION WERE REPORTED. THE CUSTOMER SERVICE REPRESENTATIVE TROUBLESHOT THE "ERROR 4" ISSUE WITH THE PATIENT AND NOTED THAT THE ISSUE WAS UNRESOLVED. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS THAT MET LIFESCAN'S CRITERIA OF A SERIOUS INJURY AFTER THE "ERROR 4" ISSUE BEGAN AND THE "ERROR 4" ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3212375

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening