BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2974559 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02051
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/16/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP'S BLACK BOX WAS REVIEWED AND SHOWED THAT THE PUMP HAD REBOOTED. A REPLACE CARTRIDGE ALARM WAS OBSERVED ON (B)(6) 2013 AT 10:22. THE ALARM WAS CONFIRMED AND DELIVERIES DID NOT RESUME UNTIL (B)(6) 2013 AT 06:38. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS. THE RETURNED BATTERY CAP HAD STRIPPED THREADS AND WAS NOT ABLE TO FULLY SECURE TO THE RETURNED PUMP OR A TEST PUMP; THE POWER LOSS WAS DUPLICATED DURING TESTING. A NEW TEST BATTERY CAP WAS ABLE TO CAREFULLY TIGHTEN TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH TEST BATTERY CAP WITH NO POWER ISSUES OCCURRING DURING TESTING WITH THE TEST CAP. THE PUMP SUCCESSFULLY COMPLETED AND PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP COVER WAS REMOVED AND NO EVIDENCE OF INTERNAL MOISTURE WAS OBSERVED. NO INTERNAL DAMAGE WAS OBSERVED ON THE PRINTED CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE PATIENT INDICATED THAT THE PUMP BATTERY COMPARTMENT WAS CRACKED. THE PUMP USER GUIDE INSTRUCTS THE USER THAT DAMAGE TO THE PUMP COULD IMPACT THE BATTERY CONTACT OR WATER PROOF FEATURE OF THE PUMP. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A HOSPITALIZATION FOR A BLOOD GLUCOSE OF 700 MG/DL WITH EXCESS URINATION AND VOMITING. THE PATIENT REPORTED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY BECAUSE THE BATTERY CAP WOULD NOT STAY SECURE TO THE PUMP. THE PATIENT REPORTED THAT OVERNIGHT THE PUMP LOST POWER AND THE PATIENT WOKE UP WITH HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING OF THE POWER ISSUE INDICATED THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77701 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L