BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2862267 · Received December 7, 2012

    Report

    Report Number
    3008382007-2012-07366
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. IT WAS NOTED THAT THE METER DISPLAYED A LINE WHEN POWERED ON. THE METER LCD WAS FOUND TO BE DEFECTIVE. 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, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER HAD A LINE GOING THROUGH THE DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE PATIENT'S MOTHER REPORTED THAT THE DISPLAY ISSUE BEGAN APPROXIMATELY 1 MONTH PRIOR TO CONTACTING LFS. SHE INFORMED THE MSS THAT THE LINE WAS GOING ACROSS THE MIDDLE OF THE DISPLAY, WHERE THE METER RESULT WAS DISPLAYED. THE PATIENT'S MOTHER STATED THAT BECAUSE OF THE DISPLAY ISSUE, A METER READING MAY HAVE BEEN MISINTERPRETED. SHE MENTIONED THAT A ZERO COULD LOOK LIKE AN EIGHT. A COUPLE OF WEEKS AFTER THE DISPLAY ISSUE BEGAN, THE REPORTER STATED THAT THE PATIENT DEVELOPED "SHAKES" AFTER HAVING TAKEN A CORRECTION BOLUS IN RESPONSE TO A BLOOD GLUCOSE RESULT OBTAINED WITH THE SUBJECT METER. THE REPORTER DID NOT RECALL THE READING OBTAINED WITH THE METER, NOR DID SHE RECALL DOSE OF INSULIN TAKEN. THE PATIENT'S MOTHER STATED THAT THE PATIENT WAS GIVEN FOOD AND/OR DRINK IN RESPONSE TO THE LOW BLOOD GLUCOSE SYMPTOM AND FELT BETTER AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO KNOWN MISUSE TO THE SUBJECT METER. THE ALLEGED METER DISPLAY ISSUE REMAINED UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    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 12 YR Life Threatening| R