BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080635 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05375
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH SUBMISSION WAS ORIGINALLY TRANSMITTED ON (B)(4) 2013, BUT THE SUBMISSION WAS UNABLE TO BE ACCEPTED DUE TO A NETWORK FILE SYSTEM ISSUE IN THE FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG) PRODUCTION SYSTEM. THE FDA ESG TEAM HAS REQUESTED THAT THIS SUBMISSION BE RE-TRANSMITTED. THE SUBMISSION DATE FOR THIS REPORT IS (B)(4) 2013 AND THE SUBMISSION WILL NOT BE CONSIDERED LATE. FOLLOW-UP #2 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 BLACK BOX INDICATED THAT REBOOTING HAD OCCURRED. THERE WAS NO PHYSICAL DAMAGE OBSERVED TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE BATTERY CAP SECURES APPROPRIATELY TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE PUMP PASSED 29 HOUR FLOW ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THERE WAS NO DAMAGE FOUND TO THE POWER CIRCUIT. THE ALLEGED POWER ISSUE COULD NOT BE DUPLICATED ON INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 06/05/2013 DEVICE EVALUATION: A RETAINED SAMPLE FROM LOT # B201860 WAS EVALUATED. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. .

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. THE REPORTER INDICATED THAT THE BATTERY COMPARTMENT WAS CRACKED AND IT WAS UNCLEAR WHEN THE BATTERY CAP WAS LAST CHANGED. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PATIENT WOKE UP WITH A BLOOD GLUCOSE OF 500 MG/DL WITH LARGE KETONES AND VOMITING RELATED TO POWER LOSS TO THE PUMP. DURING A REVIEW OF THE PUMP THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND THE BATTERY CAP WAS NOT PROPERLY SECURING. THE REPORTER STATED THAT THEY WERE UNSURE WHEN THE BATTERY CAP WAS LAST CHANGED. THE REPORTER ALSO INDICATED THAT THE PATIENT WAS RECEIVING MULTIPLE OCCLUSION ALARMS. A REVIEW OF THE OCCLUSION ALARMS INDICATED THAT THE PATIENT WAS NOT ADEQUATELY ROTATING SITES AND WAS NOT CYCLING THE CARTRIDGES PRIOR TO FILLING. THE REPORTER ALSO INDICATED THAT THE BLOOD GLUCOSE MAY NOT HAVE BEEN ENTIRELY RELATED TO THE PUMP AS THE PATIENT WAS FOUND TO HAVE EATEN A LARGE AMOUNT OF CANDY AND DID NOT GIVE A BOLUS TO COVER THE CARBOHYDRATE INTAKE. THE REPORTER ALSO INDICATED THAT THE PATIENT WAS GOING THROUGH PUBERTY WHICH MAY HAVE ALSO BEEN AFFECTING THE BLOOD GLUCOSE LEVELS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCE HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182408 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening