BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1822240 · Received September 1, 2010

    Report

    Report Number
    2939301-2010-07473
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 6, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (9/24/2012)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2010 WITH THE FOLLOWING FINDINGS: THE TEST STRIP 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

    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

    ON (B)(6) 2010, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CONTROL SOLUTION TEST WITH THE ONETOUCH PING METER WAS READING INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 AT 10:15AM. AT ABOUT THE SAME TIME PRIOR TO THE ALLEGED ISSUE, THE REPORTER CLAIMED THAT THE PATIENT WAS THIRSTY AND HUNGRY. AT AN UNKNOWN TIME BEFORE THE ALLEGED ISSUE BEGAN, THE PATIENT ALSO OBTAINED A BLOOD GLUCOSE RESULT OF "74 MG/DL" WITH THE SUBJECT METER. ACCORDING TO THE CSR DOCUMENTATION, THE PATIENT DOES NOT MANAGE HIS DIABETES WITH ORAL MEDICATION OR INSULIN; HOWEVER, AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CONSUMED AN ICE POP AND JUICE. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS WITH A SECONDARY METER AND THE DOCTOR'S OFFICE METER AT AN UNKNOWN TIME LATER; HOWEVER, THE REPORTER STATED THE PATIENT'S BLOOD GLUCOSE RESULTS WITH THE ADDITIONAL METERS WERE STILL LOW. THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY TREATMENT DURING THE DOCTOR'S OFFICE VISIT; HOWEVER, THE REPORTER STATED SHE CONTINUED TO PROVIDE JUICE TO THE PATIENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER. THE CSR ALSO NOTED THAT THE REPORTER FOLLOWED THE CORRECT CONTROL SOLUTION TESTING PROCEDURE (PER OWNER'S BOOKLET). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT WAS TREATED FOR HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. IN ADDITION, THE TREATMENT RECEIVED CORRELATED WITH RESULT THE PATIENT HAD PREVIOUSLY OBTAINED WITH THE SUBJECT METER. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED. THE ALLEGED INACCURACY ISSUE OCCURRED WITH TWO SEPARATE VIALS FROM DIFFERENT LOTS. PLEASE ALSO REFER TO MANUFACTURE REPORT# 2939301-2010-07471.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A REPORTED CONDITION OF "AIR IN LINE WHEN THERE WAS NO AIR IN THE LINE", WHICH OCCURRED DURING "PATIENT" THERAPY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3026322

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR