BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2934881 · Received January 30, 2013

    Report

    Report Number
    2531779-2013-01343
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Additional Manufacturer Narrative · 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 HISTORIES SHOWED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2013 AT 18:14, AND THE LAST BOLUS DELIVERY OCCURRED ON (B)(64) 2013 AT 13:06. REBOOTING WAS OBSERVED UPON REVIEW OF THE BLACK BOX. VISUAL INSPECTION REVEALED NO DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE BATTERY CAP ATTACHED PROPERLY TO THE PUMP WITH NO YELLOW O-RING SHOWING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER INTERRUPTIONS OCCURRING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR INTERMITTENT CONNECTIONS OBSERVED INSIDE THE PUMP. THE COMPLAINT REGARDING POWER LOSS COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT ON (B)(6) 2013, THE PATIENT'S BLOOD GLUCOSE (BG) VALUES HAD ELEVATED, WAS REMOVED OFF THE PUMP AND WAS TAKING HUMALOG INJECTIONS TO TREAT THE BG. CUSTOMER SUPPORT (CS) SPOKE WITH REPORTER ON (B)(6) 2013 AND THE REPORTER STATED THAT THERE WAS AN INTERMITTENT POWER ISSUE WITH THE PUMP AND DUE TO THE POWER ISSUE, THE PATIENT'S BLOOD GLUCOSE VALUE ROSE TO 420MG/DL. THE PATIENT REPORTEDLY BECAME MODERATELY NAUSEATED, HAD MODERATE KETONES, HAD A HEADACHE AND WENT TO THE EMERGENCY ROOM (ER). THE PATIENT REPORTEDLY WAS TREATED VIA INTRAVENOUS (IV) WITH INSULIN AND GIVEN FLUIDS AT THE E.R. THE REPORTER DENIED THAT THERE WAS MOISTURE OR DAMAGE TO THE PUMP; THERE WAS REPORTEDLY NO DAMAGE TO BATTERY COMPARTMENT OR BATTERY CAP. THE PUMP REPORTEDLY EMITTED A CALL SERVICE ALARM PRIOR TO THE POWER ISSUE. THE REPORTER STATED THAT SHE HAS BEEN USING THE SAME BATTERY TYPE FOR 2 YEARS AND HAS NEVER HAD ANY ISSUES WITH THE PUMP POWERING OFF. IT WAS NOTED THAT THE PATIENT IS DOING BETTER AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THAT THERE WAS A POWER ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41636 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L| R