BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3063863 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04427
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. 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.

    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 BLACK BOX HISTORY INDICATED A REBOOT OCCURRED PRIOR TO A ¿REPLACE BATTERY¿ ALARM; A ¿LOW BATTERY¿ WARNING WAS CONFIRMED; THE PUMP HISTORY INDICATED THAT THE TOTAL DAILY DOSE APPEARED TO BE INCONSISTENT DUE TO TIME AND DATE ISSUE. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. THE PUMP POWERED ON APPROPRIATELY WITH THE DISPLAY FUNCTIONING APPROPRIATELY. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED WITH NO DEFECTS FOUND. A ¿REPLACE BATTERY¿ ALARM WAS REPRODUCED DURING TESTING; THE PUMP GAVE THE APPROPRIATE AUDIBLE AND VISUAL ALERT. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE DISPLAY OR POWER CIRCUIT. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DISPLAY OR POWER ISSUES WERE DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. 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

    ON (B)(4) 2013, A NURSE EDUCATOR FROM THE PATIENT'S HEALTHCARE PROVIDER'S (HCP) OFFICE CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD BEEN SENT TO THE HOSPITAL WITH BLOOD GLUCOSE (BG) OVER 600MG/DL AND THAT THE PUMP'S SCREEN WAS BLANK. CUSTOMER TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, AND WAS ABLE TO REACH THE PATIENT ON (B)(6) 2013. THE PATIENT STATED THAT ON THE MORNING OF (B)(6) 2013 SHE AWOKE TO FIND THE DISPLAY SCREEN WAS BLANK AND HER BG WAS AROUND 500MG/DL WITH NAUSEA, VOMITING, EXTREME THIRST, AND LARGE KETONES. THE PATIENT STATED SHE WAS UNABLE TO GET THE PUMP TO WORK SO SHE WENT TO HER HCPS OFFICE, WHERE SHE RECEIVED AN INSULIN INJECTION. THE PATIENT NOTED THAT HER BG WAS OVER 600MG/DL AT THE HCP'S OFFICE AND THE HCP SENT HER TO THE HOSPITAL FOR ADDITIONAL TREATMENT. THE PATIENT STATED THAT WHEN SHE GOT TO THE HOSPITAL, HER BG WAS LOW AT 45MG/DL WITH NO SIGNS OR SYMPTOMS OF LOW BG. THE PATIENT WAS REPORTEDLY GIVEN IV FLUIDS AND JUICE AND WAS RELEASED ON INSULIN INJECTIONS. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT. THE PATIENT NOTED THAT THE MORNING OF (B)(6) 2013 THE SCREEN WAS BLANK BUT SHE COULD HEAR AUDIBLE TONES. THE PATIENT STATED SHE TRIED CHANGING THE BATTERY AND THE PUMP WENT TO THE VERIFY SCREEN, BUT AFTER VERIFYING THE TIME, DATE, AND BATTERY TYPE THE SCREEN WENT BLANK AGAIN WITH AUDIBLE TONES. THE PATIENT DENIED ANY TRAUMA TO THE PUMP. THE PATIENT WAS TO REMAIN ON INJECTIONS UNTIL A REPLACEMENT PUMP WAS RECEIVED. THE REPORTED LOW BG DOES NOT MEET CRITERIA FOR A SERIOUS INJURY AND WAS UNRELATED TO THE PUMP AS THE LOW BG OCCURRED AFTER SYRINGE INJECTION FROM THE HCP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WHILE ON INSULIN PUMP THERAPY POTENTIALLY RELATED TO A BLANK SCREEN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165072 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening| R