BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3030092 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03391
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 # 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: A REVIEW OF THE BLACK BOX SHOWS ON (B)(4) 2013 03:36 A ¿REPLACE CARTRIDGE¿ ALARM WAS RECORDED AND DELIVERIES RESUMED (B)(4) 2013 08:00. THE TOP OF THE RETURNED CARTRIDGE CAP WAS FOUND TO BE DAMAGED. THE THREADS OF THE RETURNED CARTRIDGE CAP WERE INTACT AND THE CAP WAS ABLE TO SECURELY TIGHTEN TO THE PUMP. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED WITH THE RETURNED CAP AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS WITH NO ISSUES OCCURRING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A NURSE CONTACTED ANIMAS ALLEGING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 WITH BLOOD GLUCOSE (BG) OVER 600MG/DL WITH KETONES, NAUSEA, AND VOMITING. THE PATIENT WAS REPORTEDLY IN THE HOSPITAL FROM (B)(6) 2013. THERE WAS NO INFORMATION PROVIDED AS TO WHAT TREATMENT THE PATIENT RECEIVED WHILE IN THE HOSPITAL. A SECOND REPORTER WAS ABLE TO PROVIDE ADDITIONAL INFORMATION. THE REPORTER NOTED THAT THE PATIENT'S BG HAD BEEN READING "HIGH" (>600MG/DL) ALL DAY ON (B)(6) 2013, AND THE PATIENT WAS TAKEN TO THE HOSPITAL THAT EVENING. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER AND FOUND THAT AN EMPTY CARTRIDGE ALARM WAS EMITTED ON (B)(6) 2013 AT 03:46 AND THE PUMP WAS NOT PRIMED UNTIL 07:57 THE SAME DAY. THIS INDICATES THE CARTRIDGE WAS NOT CHANGED FOR APPROXIMATELY FOUR HOURS AFTER THE EMPTY CARTRIDGE ALARM WAS EMITTED. THE PUMP HISTORY ALSO SHOWS SEVEN OCCLUSION ALARMS FOLLOWING A SITE CHANGE ON (B)(6) 2013 AT 07:57 AND ANOTHER OCCLUSION ALARM ON (B)(6) 2013 AT 15:08. THE REPORTER NOTED THAT THE PATIENT WAS ABLE TO PRIME THE PUMP SUCCESSFULLY AFTER EACH OCCLUSION ALARM. THE OCCLUSION ALARMS WERE REPORTEDLY OCCURRING DURING BASAL DELIVERY. THE PATIENT'S ELEVATED BG WAS REPORTEDLY BEING TREATED BY INSULIN PEN PRIOR TO HOSPITALIZATION. THE REPORTER DID NOT NOTE ANY SITE OR SET ISSUES. ALL PUMP SETTINGS AND HISTORIES WERE FOUND TO BE CORRECT UPON REVIEW. THE BASAL DELIVERY TOTAL FOR THE DAY OF THE MULTIPLE OCCLUSION ALARMS WAS FOUND TO BE LESS THAN USUAL. THE REPORTER STATED THAT THE PATIENT'S SITE IS CHANGED EVERY THREE DAYS AND DEMONSTRATED APPROPRIATE SITE ROTATION. THE INSULIN IS REPORTEDLY STORED IN THE REFRIGERATOR BUT THE CURRENT VIAL IN USE IS KEPT AT ROOM TEMPERATURE AS RECOMMENDED. THE REPORTER CONFIRMED THE INSULIN IS CLEAR AND IS NOT EXPIRED. THE REPORTER NOTED THAT THE PATIENT WAS PUT ON ANTIBIOTICS FOR A THROAT INFECTION UPON HOSPITALIZATION. THE PATIENT IS REPORTEDLY CURRENTLY OFF THE PUMP AND USING AN ALTERNATE METHOD OF INSULIN DELIVERY DUE TO THE CARTRIDGE CAP BEING BROKEN AND NOT SECURING PROPERLY. CTS DETERMINED THROUGH TROUBLESHOOTING THAT THE REPORTED BG EXCURSION WAS DUE TO INADEQUATE RESPONSE TO AN APPROPRIATELY EMITTED EMPTY CARTRIDGE ALARM, MULTIPLE OCCLUSION ALARMS INTERRUPTING BASAL DELIVERY, AND THE THROAT INFECTION. CTS DETERMINED THAT THE REPORTED INCIDENT WAS NOT RELATED TO A POSSIBLE MALFUNCTION OF THE PUMP. THE OCCLUSION ALARMS WERE ATTRIBUTED TO THE INFUSION SET. ANIMAS DOES NOT MANUFACTURE THE INFUSION SET BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SEVERE HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY WITH INADEQUATE RESPONSE TO AN APPROPRIATELY EMITTED ALARM AS A CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134705 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L| R