BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3082012 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09368
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    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
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THE COMPLAINT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER UP AND ARROW BUTTONS WERE "SCROLLING TOO FAST" SO SHE WAS UNABLE TO MEDICATE CORRECTLY. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 12PM. THE PATIENT REPORTED SHE WAS UNABLE TO SEE THE HIGH READING DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED SHE USES INSULIN PUMP THERAPY TO MANAGE HER DIABETES AND SHE TESTS MORE THAN 4 TIMES A DAY. THE PATIENT BELIEVED HER BLOOD GLUCOSE WAS HIGH, GREATER THAN "600MG/DL" THEREFORE SHE BOLUSED AN UNKNOWN AMOUNT OF INSULIN ON (B)(6) 2013 AT 12PM. THE PATIENT REPORTED 1 HOUR LATER, SHE DEVELOPED SYMPTOMS OF "NAUSEA" THEREFORE SHE SELF ADMINISTERED 4MG OF ONDANSETRON ON (B)(6) 2013 AT 1PM. THE PATIENT REPORTED THEN CALLING HER DOCTOR AND WAS ADVISED TO GO TO THE HOSPITAL. THE PATIENT REPORTED SHE ARRIVED AT THE HOSPITAL ON (B)(6) 2013 AT 2PM AND VOMITED ON ARRIVAL. THE PATIENT REPORTED A BLOOD GLUCOSE READING OF "589MG/DL" WAS OBTAINED AND SHE WAS TREATED WITH AN INSULIN DRIP AND ADMITTED. THE PATIENT REPORTED SHE WAS KEPT OVERNIGHT AND RELEASED THE NEXT MORNING AT 9AM. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED, AND THERE WAS NO MISUSE OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT CONFIRMED. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO MEDICATE HERSELF PROPERLY, A SEVERELY HIGH BLOOD GLUCOSE READING WAS OBTAINED, AND SHE REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR AN ACUTE COMPLICATION OF DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184853 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3376996

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R