BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2182914 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06563
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (09/07/2011) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT'S FATHER CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INTERMITTENT POWER ISSUE WITH HIS DAUGHTER'S ONE TOUCH PING METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE FATHER REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER NOT TURNING ON BEGAN IN THE MIDDLE OF THE DAY, AT THE END OF (B)(6) 2011. HE STATED THAT HIS DAUGHTER MANAGES HER DIABETES WITH NOVOLOG INSULIN (PUMP THERAPY), AND DUE TO THE ALLEGED POWER ISSUE WITH THE SUBJECT METER, HER USUAL DOSE OF INSULIN WAS ADMINISTERED MANUALLY VERSUS THROUGH THE PUMP. THIS MANUAL ADMINISTRATION CONTINUED FOR 3 WEEKS. THE FATHER CLAIMED THAT HIS DAUGHTER BECAME IRRITABLE, A "FEW DAYS" AFTER THE PRODUCT ISSUE BEGAN. HE DENIED THAT SHE RECEIVED ANY MEDICAL TREATMENT IN RESPONSE TO HER SYMPTOM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOM DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, ALTHOUGH CUSTOMER SERVICE WAS UNABLE TO CONFIRM THE ISSUE, THE ALLEGED PRODUCT ISSUE REPORTEDLY HAS HAPPENED INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3108417

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR