BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2931410 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01228
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE PATIENT INDICATED THAT THE PUMP WAS EXPOSED TO X-RAY; THE PUMP USER GUIDE INSTRUCTS THE PATIENT NOT TO EXPOSE THE PUMP TO X-RAY, MRI, OR CAT SCAN. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX INDICATED THE FOLLOWING: A REPLACE CARTRIDGE ALARM OCCURRED AT 08:12 ON (B)(4) 2012; THE ALARM WAS CONFIRMED AND DELIVERIES WERE RESUMED THAT SAME DAY AT 09:48. A REPLACE CARTRIDGE ALARM OCCURRED AT 06:29 ON (B)(4) 2012; THE ALARM WAS CONFIRMED AND DELIVERIES WERE RESUMED THAT SAME DAY AT 13:14. A REPLACE CARTRIDGE ALARM OCCURRED AT 05:59 ON (B)(4) 2012; THE ALARM WAS CONFIRMED AND DELIVERIES WERE RESUMED THAT SAME DAY AT 07:06. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY WITH NO ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR WARNINGS OCCURRING. DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE PROGRAMMED BASAL RATES. THE PUMP PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING BLOOD GLUCOSE LEVELS OF 325 TO 400 MG/DL WITH POSITIVE KETONES AND MILD FATIGUE. THE PATIENT REPORTED DISCONTINUING USE OF THE PUMP IN FAVOR OF A BACK UP TREATMENT PLAN. THE PATIENT REPORTED THAT THE PUMP WAS EXPOSED TO X-RAY ON (B)(6) 2012 VIA A FULL BODY SCANNER AT THE AIRPORT. THE PATIENT REPORTED THAT SINCE THE EXPOSURE TO X-RAY, THE PATIENT WAS EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT REPORTED BEING UNSURE OF THE DATES OF THE ELEVATED BLOOD GLUCOSE LEVELS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AFTER THE PUMP WAS EXPOSED TO X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37637 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening