BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050745 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-04005
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT PUMP WAS SUSPENDED ON (B)(4) 2013 AND THE SUSPEND WAS CONFIRMED MULTIPLE TIMES AND DELIVERIES WERE RESUMED ON (B)(4) 2013. THE HISTORY SHOWS THE LAST BASAL DELIVERY WAS ON (B)(4) 2013. DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE ALARM HISTORY; THERE WERE NO ALARMS RELATED TO THE COMPLAINT RECORDED. ON (B)(4) 2013 A MANUAL TIME CHANGE WAS OBSERVED. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. INVESTIGATORS, WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION PROCESS.

    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 HAD BLOOD GLUCOSE LEVELS OF 400-600 MG/DL WITH LETHARGY AND OVERALL WEAKNESS. THE REPORTER STATED THAT THE INSULIN WAS CHANGED OUT WITHOUT IMPROVEMENT TO THE BLOOD GLUCOSE LEVELS. THE PUMP WAS REVIEWED AND CONFIRMED THAT THE TOTAL DAILY DOSE CORRECTLY REFLECTED THE BASAL AND BOLUS AMOUNTS. THE REVIEW OF THE PRIME HISTORY FOUND THAT THE FILL CANNULA STEP WAS NOT BEING COMPLETED. THE REPORTER INDICATED THAT IS THE WAY IT WAS DONE SINCE THE PATIENT STARTED ON THE PUMP AND WAS NOT AN ISSUE BEFORE. THE REPORTER ALSO ADMITTED THAT THE PATIENT WAS OFTEN LEAVING IN THE SITE FOR UP TO 5 DAYS. THE REPORTER INDICATED THAT NOW THE SITES WERE BEING REPLACED MUCH MORE OFTEN AND THE BLOOD GLUCOSE LEVELS PERSISTED. THE REPORTER STATED THAT THE PATIENT WAS NOW DISCONNECTED FROM THE PUMP AND TREATING USING INJECTIONS. THE REPORTER WAS ADVISED THAT THERE WAS NO EVIDENCE OF AN ISSUE WITH THE PUMP DELIVERY. THE REPORTER WAS ADVISED ON THE IMPORTANCE OF FILLING THE CANNULA AND CHANGING THE SITES EVERY 2-3 DAYS PER THE INSTRUCTIONS FOR USE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN IMPLIED ALLEGATION OF A PUMP DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149633 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening