BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3103222 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06096
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #3 DATE OF SUBMISSION 07/15/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/29/2015 WITH THE FOLLOWING FINDINGS:THE BLACK BOX DATA STARTED ON 05/06/2015. THE BLACK BOX DATA AND PUMP HISTORIES FROM THE TIME OF THE REPORTED INCIDENT WERE UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE AVAILABLE 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

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE CERTIFIED DIABETES EDUCATOR (CDE) CONTACTED ANIMAS ON BEHALF OF THE PATIENT STATING THAT THE PATIENT HAD BEEN SEEN IN THE ER NINE TIMES AND ADMITTED TO THE HOSPITAL FOUR TIMES SINCE (B)(6) DUE TO POOR DIABETES CONTROL AND ISSUES WITH DIABETIC KETOACIDOSIS. THE CDE STATED HOSPITALIZATIONS HAD BEEN DUE TO BOTH HIGH AND LOW BLOOD GLUCOSE (BG), AS LOW AS 35MG/DL AND AS HIGH AS 600MG/DL. THE PATIENT WAS REPORTEDLY IN THE HOSPITAL AT THE TIME OF THE CALL STILL ON INSULIN PUMP THERAPY AND BEING CLOSELY MONITORED. THE PATIENT WAS REPORTEDLY RECEIVING ASSISTANCE FROM THE NURSES TO BOLUS AND THE NURSES ARE CHECKING THE PATIENT'S BGS FREQUENTLY. THE CDE STATED THAT SHE REVIEWED THE PUMP AND DID NOT BELIEVE THERE WERE ANY ISSUES WITH THE PUMP; THE PUMP APPEARS TO BE FUNCTIONING APPROPRIATELY. THE CDE NOTED THAT THE PATIENT HAS GASTROPARESIS AND OTHER COMPLICATIONS FROM DIABETES AND THAT HIS BGS ARE EXTREMELY DIFFICULT TO CONTROL. THE CDE THINKS THAT THE PATIENT IS SOMEWHAT NON-COMPLIANT IN HIS DIABETES CARE. THE CDE STATED SHE FEELS THE PATIENT NEEDS ADDITIONAL PUMP TRAINING AND REQUESTED A CLINICAL MANAGER CONTACT THE PATIENT. ALTHOUGH THE CDE DENIED ANY PUMP MALFUNCTION, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WHILE USING INSULIN PUMP THERAPY WITH MISUSE OF THE PUMP AS A POTENTIAL CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202631 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R