BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2816934 · Received November 2, 2012

    Report

    Report Number
    2531779-2012-13080
    Event Type
    Injury
    Date Received
    November 2, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO DAMAGE FOUND TO BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP SECURED TIGHTLY TO THE PUMP. THE PUMP POWERED ON WITH NO ISSUES AND NO ALARMS. THE BATTERY CAP MET ALL REQUIRED SPECIFICATIONS. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO POWER CIRCUIT. NO POWER ISSUES OR ALARMS WERE NOTED DURING TESTING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS INQUIRING WHEN THE PATIENT'S REPLACEMENT PUMP WAS GOING TO ARRIVE. AT THE TIME OF THE CALL, THE REPORTER INFORMED CUSTOMER SUPPORT THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AT 4:30AM WITH AN ADMITTING BLOOD GLUCOSE (BG) OF 384 MG/DL AND A DIAGNOSIS OF DKA. THE PATIENT'S MOTHER STATED THE PATIENT WAS STARTED ON IV INSULIN DROP. THE PATIENT'S MOTHER STATED SHE TOOK THE PATIENT OFF OF THE PUMP ON (B)(6) 2012 AFTER SHE CONTACTED CUSTOMER SUPPORT DUE TO ISSUES WITH PUMP. THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 TO REPORT THAT THE PUMP HAD POWERED OFF WHEN THE PATIENT WAS SLEEPING AND HAD GIVEN A CALL SERVICE ALARM. BOTH ISSUES WERE RESOLVED WITH TRAINING. THE SUBJECT PUMP WAS REPLACED BECAUSE IT WAS DISCOVERED THAT THE PUMP WAS RESETTING TO THE DEFAULT DATE/TIME WITH PUMP REBOOT AND/OR BATTERY CHANGE. THE PATIENT'S MOTHER WAS EDUCATED ON UPDATING PUMP'S DATE AND TIME. THE PATIENT'S MOTHER INFORMED CUSTOMER SUPPORT THAT WHEN SHE TOOK THE PATIENT OFF THE PUMP SHE REFUSED TO PUT HIM ON LANTUS AND WAS JUST GIVING INJECTIONS OF NOVOLOG. PER THE DOCUMENTATION, THE PATIENT'S HCP SUGGESTED PATIENT BE PUT ON LANTUS FOR BACKUP PLAN. AT AN UNSPECIFIED DATE/TIME, THE PATIENT DEVELOPED SYMPTOMS OF NAUSEA, VOMITING, ABDOMINAL CRAMPS AND TESTED POSITIVE FOR KETONES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY HOSPITALIZED WITH A DIAGNOSIS OF DKA AFTER DISCONTINUING INSULIN PUMP THERAPY DUE TO PUMP ISSUES. THE ALLEGED HYPERGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR, SINCE THE PATIENT'S MOTHER REFUSED TO USE APPROPRIATE BACKUP PLAN WHEN THE PATIENT WAS DISCONNECTED FROM THE SUBJECT PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| L| R