BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071119 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04759
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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

    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 PUMP HISTORY SHOWS THAT THE LAST BASAL DELIVERY AND LAST BOLUS DELIVERY OCCURRED ON (B)(4) 2013. THE TOTAL DAILY DOSE HISTORY FOR THE DATE OF THE EVENT, (B)(4) 2013, APPEAR TO BE LOW. A REVIEW OF THE ALARM HISTORY SHOWS A ¿REPLACE BATTERY¿ ALARM ON (B)(4) 2013 AT 18:21; THE PRIME HISTORY SHOWS THAT THE PUMP WAS NOT PRIMED UNTIL (B)(4) 2013 AT 19:29. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT'S BLOOD GLUCOSE (BG) ELEVATED TO "HI" (>600MG/DL) DUE TO THE PUMP NOT DELIVERING INSULIN. THE REPORTER STATED THAT THE PATIENT WAS TREATED WITH A CORRECTION INJECTION FOR THE ELEVATED BG. THE REPORTER NOTED THAT THE PATIENT WAS UNABLE TO PRIME THE PUMP, STATING THAT WHEN ATTEMPTING TO PRIME, THE MOTOR SOUNDS LABORED AND SLOW. A REVIEW OF THE PUMP'S ALARM HISTORY SHOWS A LOW CARTRIDGE WARNING, AND EMPTY CARTRIDGE ALARM, OCCLUSION ALARMS, CALL SERVICE ALARMS, AND REPLACE BATTERY ALARMS ON THE EVENT DATE. THE EMPTY CARTRIDGE ALARM OCCURRED AT 15:23, AND THE CALL TO CUSTOMER TECHNICAL SUPPORT (CTS) WAS AT 18:15, AND THE CARTRIDGE HAD NOT BEEN CHANGED INDICATING THE PATIENT WAS WITHOUT INSULIN DURING THAT TIME. TROUBLESHOOTING COULD NOT DETERMINE IF THE PUMP WAS NOT DELIVERING DUE TO INABILITY TO PRIME OR DUE TO THE PATIENT NOT RESPONDING TO THE EMPTY CARTRIDGE ALARM. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING AS EXPECTED AND THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172618 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening