BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2850750 · Received November 29, 2012

    Report

    Report Number
    3008382007-2012-06890
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 8, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 ((B)(4)) DEVICE EVALUATION: THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS FAILED TESTING THE LCD WAS FOUND TO BE CRACKED OR BROKEN. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER HAD BLACK MARKS ON THE DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST STARTED. THE PATIENT REPORTED USING INSULIN PUMP THERAPY TO MANAGE HIS DIABETES. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. AT AN UNKNOWN TIME AND DATE THE PATIENT REPORTED FEELING "DIZZY AND WEAK". THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED, AND THERE WAS NO MISUSE OF THE PRODUCT. THE CCA WAS UNABLE TO RUN A RETEST SINCE THE PATIENT DID NOT HAVE TEST STRIPS AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT. THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE LCD WAS FOUND TO BE CRACKED OR BROKEN. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTED SYMPTOMS DO NOT MEET LFS'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS OR MEDICAL INTERVENTION WHICH SUGGESTS A SERIOUS INJURY OCCURRED. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING DONE BY THE CCA AND BECAUSE OF THE FINDINGS FROM PRODUCT ANALYSIS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1