BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3772125 · Received April 7, 2014

    Report

    Report Number
    3009351200-2014-00003
    Event Type
    Other
    Date Received
    April 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ASANTE SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE EVAL CONFIRMED THAT 9 BLOCKED INFUSION SET ALARMS OCCURRED WITH DELAYED PT RESPONSE TO ADDRESS THE ALARMS. HOSPITAL TESTS INDICATE A NEUROLOGICAL CONDITION WAS DISCOVERED THAT LIKELY CONTRIBUTED TO THE PT'S ABILITY TO PROPERLY USE THE ASANTE SNAP INSULIN PUMP SYSTEM.

    Description of Event or Problem · 1

    ASANTE CLINICAL MANAGER (CM) REC'D PHONE CALL FROM PT'S WIFE INDICATING PT WAS ADMITTED TO ICU WITH DIABETIC KETOACIDOSIS (DKA). PT WAS ON A 30-DAY TRIAL OF THE ASANTE SNAP INSULIN PUMP SYSTEM SINCE (B)(6) 2014 (19 DAYS). WIFE STATED THAT THE ASANTE PUMP WAS ALARMING ALL DAY ON (B)(6) 2014 AND PT DID NOT ADDRESS ANY ALARMS AND TOOK THE PUMP OFF. WIFE CALLED 911 FOR PT'S MENTAL STATUS CHANGES, NAUSEA AND VOMITING. CM PLACED CALL TO PT'S CERTIFIED DIABETES EDUCATOR (CDE) TO CONTACT THE PT AND PHYSICIAN. AT HOSPITAL, CDE REVIEWED THE DEVICE ALARM HISTORY WITH PT'S WIFE. CDE REPORTED THAT PT REC'D CONTINUOUS "BLOCKED INFUSION SET" ALARMS FOR THE LAST COUPLE OF DAYS. THE PT REPEATEDLY IGNORED THE ALARM AND DID NOT LOOK TO ADDRESS THE ISSUE HIMSELF OR CONTACT ASANTE CUSTOMER SUPPORT. PT EVENTUALLY REMOVED THE PUMP SYSTEM ENTIRELY. ER NURSE NOTED IN PT RECORD THAT NO DEVICE MALFUNCTION OCCURRED AND THAT CIRCUMSTANCES APPEARED TO BE PT ERROR. ACCORDING TO THE ATTENDING PHYSICIAN AS WELL AS THE CDE, THEY ARE CONCERNED THE PT HAS ADD'L COMPLICATIONS (UNRELATED TO THE EVENT) AND ARE PUTTING HIM THROUGH A BATTERY OF TESTS. AS OF (B)(6) 2014, ALL NOTES ON THE PT'S CHART INDICATED THAT HE WAS ON THE SNAP INSULIN PUMP SYSTEM, BUT THE PUMP WAS WORKING LIKE IT WAS SUPPOSE TO WORK AND IN ADDITION HIS ISSUES ARE WELL BEYOND HIS IGNORED PUMP ALARMS. ON (B)(6) 2014 THE CM REPORTED THAT, WHILE ADMITTED TO THE HOSPITAL, THE PT HAD A NEURO WORKUP THAT REVEALED AN AGGRESSIVE NEW ORGANIC DEMENTIA. HE WAS HOME BY THIS DATE AND DOING BETTER, HOWEVER, HE HAD BEHAVIORAL CHANGES ALONG WITH COGNITIVE CHANGES THAT ARE MAKING HIS DIABETES MANAGEMENT CARE VERY DIFFICULT. FOR NOW, THE PT WILL BE STAYING OFF THE ASANTE INSULIN PUMP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209783 ASANTE SNAP INSULIN PUMP SYSTEM EXTERNAL INSULIN INFUSUION PUMP LZG ASANTE SOLUTIONS, INC. 7113 CM 131630015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R