BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2890032 · Received December 28, 2012

    Report

    Report Number
    3008382007-2012-09083
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS FOUND TO FUNCTION PROPERLY WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER DISPLAYED AN "ERROR 5" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN "A FEW DAYS" PRIOR TO CONTACTING LFS FOR ASSISTANCE. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN THROUGH PUMP THERAPY. THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. AT AN UNKNOWN DATE/TIME BEFORE THE ALLEGED ISSUE BEGAN, THE REPORTER CLAIMS THE PATIENT HAD SYMPTOMS OF STOMACH ACHE, DARK CIRCLES AROUND THE EYES AND LETHARGY AND VOMITING. ON (B)(6) 2012 AT 10:30AM, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF "79 MG/DL" WITH THE ER/ HOSPITAL METER. THE REPORTER DENIED THE PATIENT RECEIVED MEDICAL TREATMENT SINCE THE PATIENT'S BLOOD GLUCOSE WAS WITHIN A "NORMAL RANGE." THE CCA WAS NOT ABLE TO WALK THE REPORTER THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED "ERROR 5" MESSAGE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3331208

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR