BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2896757 · Received January 4, 2013

    Report

    Report Number
    2531779-2013-00171
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: MULTIPLE REPLACE BATTERY ALARMS OBSERVED IN BLACK BOX. SECONDARY ERROR CODE IS DEFINED AS A POST DELIVERY MOTOR POWER SUPPLY FAULT. ON (B)(4) 2012 MULTIPLE REPLACE BATTERY ALARMS BEGINNING AT 11:29AM; INSULIN DELIVER RESUMES 4:09PM. WHEN ATTEMPTING THE "REWIND" STEP PUMP GIVES A REPLACE BATTERY ALARM UNABLE TO PERFORM STEPS 20-23, 30 DUE TO RECURRING REPLACE BATTERY ALARM. WHEN PUMP WAS OPENED AND SOLDER TO THE U12 COMPONENT WAS REFLOWED; PUMP WAS ABLE TO REWIND WITHOUT ALARM THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE PATIENT EXPERIENCED A BLOODG LUCOE OS 555 MG/DL WITH EMESIS. THE REPORTER STATED THAT THE PUMP EMITTED MULTIPLE REPLACE BATTERY ALARMS WHILE AT SCHOOL. THE REPORTER STATED THAT AN ENERGIZER ADVANCED LITHIUM BATTERY WAS INSERTED INTO THE PUMP AND THE PUMP CONTINUED TO GET REPLACE BATTERY ALARMS; THE REPORTER STATED THAT NO OTHER TYPES OF BATTERIES WERE AVAILABLE AT SCHOOL. CUSTOMER SUPPORT ADVISED THE REPORTER AGAINST THE USE OF THE ENERGIZER ADVANCED LITHIUM BATTERIES IN THE PUMP; THE REPORTER WAS INSTRUCTED THAT ENERGIZER ULTIMATE LITHIUM BATTERIES WERE RECOMMENDED IN THE PUMP. THE ALARM HISTORY WAS REVIEWED AND FOUND A LOW BATTERY ALARM AT 6:28 AM AND SEVERAL REPLACE BATTERY ALARMS BETWEEN 11:29 AM AND 12:34 PM. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO BATTERY ALARMS CAUSED BY USING THE INCORRECT BATTERY TYPE IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4401 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening