BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2143585 · Received June 29, 2011

    Report

    Report Number
    2531779-2011-04559
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION BOLUSES WERE ABLE TO BE PROGRAMMED, DELIVERED AND RECORDED CORRECTLY IN THE PUMP HISTORY. A LOW CARTRIDGE WARNING WAS INDUCED AND THE PUMP GAVE THE APPROPRIATE ALARM. THE ALARM WAS PROPERLY RECORDED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING THAT THE DELIVERY HISTORY OF A PUMP WAS INACCURATE. THE PUMP'S BASAL HISTORY WAS REVIEWED AND FOUND TO BE CORRECT. THE BOLUS HISTORY WAS ALSO REVIEWED AND THE FOLLOWING OBSERVATIONS WERE NOTED: ON (B)(6), THERE WERE NO BOLUSES RECORDED BUT IN THE TDD, 5.05U WERE REPORTEDLY NOTED. THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT WALKED THE REPORTER THROUGH AN AIR BOLUS AND THE PUMP DELIVERED THE BOLUS. THE REPORTER SAW DROPS COMING OUT THE END OF THE TUBING AND THE PUMP RECORDED THE BOLUS CORRECTLY WITH 4.5U DELIVERED ON (B)(6). THE TDD WAS REVIEWED AGAIN FOR (B)(6), AND THE BOLUS TDD NOW READ 9.10U. THE BOLUSES FOR JUNE 2 WERE ADDED UP AND THE BOLUS HISTORY DISPLAYED 8.8U; WHEREAS THE TDD SHOWED 8.35U. FOR (B)(6), THE BOLUS HISTORY SHOWED 12.4U AND THE TDD REPORTEDLY SHOWED 5.50U. THE REPORTER DENIED CHANGING THE TIME/DATE ON THE PUMP. SHE ALSO CLAIMED THERE WERE BOLUSES MISSING THAT THEY KNEW WERE DELIVERED DUE TO THE PATIENT'S BG RESPONDING. NO ALARMS WERE NOTED IN THE ALARM HISTORY. NO INADVERTENT PRIMES WERE NOTED. THE REPORTER CONFIRMED THAT THE PUMP DID NOT REBOOT. THE BATTERY CAP WAS SECURE TO THE PUMP AND NO CRACKS WERE NOTED. THE YELLOW O-RING WAS NOT VISIBLE. THE KEYPAD WAS WORN, THIN, AND LOOSE BUT THE BUTTONS WERE RESPONDING NORMALLY. THE PATIENT NOTICED THE EMPTY CART ALARM AT 8:59AM, AND HER BG LEVEL WAS 46 MG/DL. SHE TOOK HERSELF OFF OF THE PUMP AND CORRECTED THE BG WITH JUICE, FOOD, AND GLUCOSE TABS. THE PATIENT'S BG INCREASED TO 67MG/DL. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP HAD AN INACCURATE DELIVERY HISTORY. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY SYMPTOMS OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    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 11 YR