BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2955222 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01684
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #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 PUMP HISTORY REVEALED THE LAST BASAL AND BOLUS DELIVERY WAS ON (B)(6) 2013. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THERE WERE NO ERRORS OR ALARMS ASSOCIATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY;ONLY TYPICAL USAGE WAS OBSERVED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE REPORTED INACCURATE DELIVERY WAS NOT DUPLICATED DURING THE INVESTIGATION.

    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. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT IS HOME FROM SCHOOL BECAUSE THEY ARE NOT FEELING WELL. THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 537MG/DL WITH NAUSEA, HEADACHE AND NOT FEELING WELL. THE REPORTER STATED THAT THEY WERE UNABLE TO ADMINISTER THE BOLUS VIA PUMP DUE TO TECHNICAL ISSUES AND CUSTOMER SUPPORT (CS) ADVISED THE REPORTER TO CONTACT THE HEALTHCARE PROFESSIONAL (HCP) TO OBTAIN ORDERS FOR CORRECTION BY ALTERNATE METHOD OF TREATMENT WITH INJECTIONS. THE REPORTER CONTACTED HCP AND WAS INSTRUCTED TO ADMINISTER LANTUS INSULIN UNTIL THE PUMP IS REPLACED. THE REPORTER DENIED THAT THE PUMP WAS AT FAULT FOR THE ELEVATED BGS AND STATES THAT THE HCP BELIEVED IT COULD BE POSSIBLY BE THE INSULIN BASAL RATES AND THAT THE PATIENT WILL BE GOING TO THE HCP FOR AN APPOINTMENT ON (B)(6) 2013 AFTER DELIVERY OF THE NEW PUMP. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58381 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening