BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2180538 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06495
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 510K # IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6) 2011 THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. ON (B)(6) 2011, THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. HOWEVER, A SECONDARY ISSUE WAS NOTED, THE METER WAS FOUND TO HAVE A DAMAGED LCD. 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH PING METER REMOTE WAS READING INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT ON TWO SEPARATE OCCASIONS HE OBTAINED A MESSAGE OF "LOW GLUCOSE" INSTEAD OF A BLOOD GLUCOSE READING WHEN HE TESTED WITH THE SUBJECT METER. PER THE ONETOUCH PING OWNER'S BOOKLET, THE METER DISPLAYS THIS MESSAGE IF A BLOOD GLUCOSE LESS THAN 20 MG/DL HAS BEEN DETECTED. THE PATIENT STATED THAT HE FIRST OBTAINED THE MESSAGE ON (B)(6) 2011 (TIME NOT CLEAR). THE PATIENT INFORMED THE CSR THAT HE WAS FEELING HUNGRY AND IN RESPONSE TO THE SYMPTOM HE TESTED HIS BLOOD GLUCOSE. THE PATIENT STATED HE FELT HIS BLOOD GLUCOSE WAS RUNNING LOW, HOWEVER, HE DID NOT FEEL HE WAS "THAT LOW". THE PATIENT REPORTED TREATING HIMSELF WITH JUICE AND IN RESPONSE TO THE MESSAGE DECREASED HIS BASAL RATE ON HIS INSULIN PUMP. ON THE FOLLOWING DAY (AT APPROXIMATELY 10:30AM), THE PATIENT CLAIMED HE OBTAINED THE "LOW GLUCOSE" MESSAGE AGAIN. AT THE TIME OF THE TEST, THE PATIENT DENIED HAVING ANY SYMPTOMS. HOWEVER, IN RESPONSE TO THE MESSAGE THE PATIENT STATED HE ATE COOKIES, DRANK JUICE AND DECREASED HIS BASAL RATE ON HIS PUMP (FROM 1 UNIT/HR TO 0.5 UNIT/HR). AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT CODE NUMBER AND THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE MESSAGE/RESULT OBTAINED WITH THE SUBJECT METER DID NOT CORRELATE WITH THE PATIENT'S FEELINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3142943

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR