BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3810006 · Received May 14, 2014

    Report

    Report Number
    2531779-2014-13514
    Event Type
    Injury
    Date Received
    May 14, 2014
    Report Date
    May 6, 2014
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 01/07/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA AND HISTORIES FROM THE TIME OF THE ALLEGED INCIDENT WERE UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. THE PUMP WAS RETURNED WITH THE MAX DAILY DELIVERY SET TO 150UNITS; THE DOWNLOAD AND BLACK BOX DID NOT SHOW ANY DELIVERIES EXCEEDING THAT AMOUNT. A REVIEW OF THE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF CURRENT THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON AN UNSPECIFIED DATE THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 540MG/DL AND STATED THAT THE PATIENT HAD BEEN ¿HAVING PROBLEMS WITH THE PUMP FOR SIX MONTHS¿. THE REPORTER NOTED THAT THE PATIENT HAD NEVER CALLED IN FOR TROUBLESHOOTING PRIOR TO THIS CONTACT. REPORTEDLY, THE PUMP EMITTED A ¿MAX WARNING, NO DELIVERY¿ ALARM ON (B)(6) 2014. ADDITIONAL INFORMATION WAS NOT PROVIDED AND THE PUMP WAS UNAVAILABLE FOR REVIEW AT THE TIME OF INITIAL CONTACT. CUSTOMER TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO REACH THE PATIENT FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A NON-SPECIFIC PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288603 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening