BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882605 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14953
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DUE TO CONTINUED USE OF THE PUMP, THE HISTORY FROM THE COMPLAINT EVENT DATE WAS OVERWRITTEN. THERE WERE NO ERRORS OR ALARMS RELATED TO THE COMPLAINT OBSERVED. THE USERS PROGRAMMED BASAL RATES ARE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. DURING TESTING, A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A REPLACE CARTRIDGE ALARM WAS REPRODUCED FOR TESTING, THE PUMP GAVE THE APPROPRIATE AUDIBLE WARNING AND DISPLAYED THE CORRECT MESSAGE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S SPOUSE CONTACTED ANIMAS TO REPORT HIGH BLOOD GLUCOSE (BG) EXCURSIONS. THE REPORTER INFORMED CUSTOMER SUPPORT THAT ON (B)(6) 2012, THE PATIENT OBTAINED A BG OF 577 MG/DL UPON WAKING UP FROM A NAP AT AROUND 6PM. THE PATIENT'S SPOUSE STATED THE PATIENT HAD SYMPTOMS OF NAUSEA AND CONFUSION WITH THE HIGH BG. IN RESPONSE TO THE HIGH BG, THE PATIENT CHANGED OUT SITE/SET AND TOOK INSULIN VIA THE PUMP. THE PATIENT'S WIFE INFORMED CUSTOMER SUPPORT THAT THE PATIENT HAD HAD FACIAL SURGERY EARLIER THAT DAY AND WAS TAKING PAIN MEDICATION. THE REPORTER INFORMED CUSTOMER SUPPORT THAT AFTER CHANGING OUT THE SITE/SET THE PATIENT WENT BACK TO SLEEP. ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT EXPERIENCED A HIGH BG IN THE 500 MG/DL RANGE ACCOMPANIED BY VOMITING UPON WAKING THAT MORNING. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WITH A BG OF 824 MG/DL. WHILE HOSPITALIZED, INSULIN PUMP THERAPY WAS DISCONTINUED AND THE PATIENT WAS TREATED WITH IV HYDRATION AND AN INSULIN DRIP. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT'S BG WAS REPORTED TO BE 110 MG/DL. THE PATIENT WAS REPORTEDLY RESUMING INSULIN PUMP THERAPY THE DAY OF THE CALL TO ANIMAS, (B)(6) 2012. AT THE TIME OF ADMISSION TO THE HOSPITAL, THE PATIENT NOTICED THE PUMP WAS LEAKING AT THE LUER LOCK CONNECTION. THE REPORTER CONFIRMED THERE WAS NO DAMAGE TO THE LUER LOCK OR THE CARTRIDGE. THE REPORTER STATED THAT THE LEAK WAS DUE TO HUMAN ERROR AS THE PATIENT WAS CONFUSED WHEN CHANGING OUT THE LAST CARTRIDGE AND DID NOT ENSURE A PROPER CONNECTION AT THE LUER LOCK. THE REPORTER STATED THE PATIENT HAD FACIAL SURGERY ON 11/27/2012 AND HAD BEEN TAKING HYDROCODONE FOR PAIN AT THE TIME. IT WAS ALSO DISCOVERED DURING THE CALL TO ANIMAS THAT THE CARTRIDGE USED BY THE PATIENT WAS EXPIRED (LOT #B201109, EXP 2008-07). ANIMAS CUSTOMER TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OF THE PUMP AND NO MALFUNCTION WAS IDENTIFIED. THE REPORTER STATED THAT SHE BELIEVED THE PATIENT WAS IN NEED OF BG MANAGEMENT DUE TO MULTIPLE ISSUES INCLUDING USING EXPIRED CARTRIDGES, NOT CHANGING OUT AN EMPTY CARTRIDGE FOR FOUR HOURS AFTER RECEIVING THE PUMP ALARM AND NOT SECURING THE LUER LOCK CONNECTION ON THE SET PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HOSPITALIZATION FOR ELEVATED BG RESULTING FROM IMPROPER USE OF THE INSULIN CARTRIDGE AND INFUSION SET. NO PRODUCT IS BEING RETURNED.

    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 66 YR Hospitalization| L| R