BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2910963 · Received January 11, 2013

    Report

    Report Number
    2531779-2013-00542
    Date Received
    January 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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, HOWEVER USE ERROR CANNOT BE DISCOUNTED AS CONTRIBUTING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: (B)(6) 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 HISTORY SHOWS ALL BOLUSES AND BASALS WERE DELIVERED AS PROGRAMMED AND THEY CORRECTLY ADD UP AND EQUAL THE TOTAL DAILY DOSE INSULIN TOTALS. THE BLACK BOX AND ALARM HISTORY SHOW NO ERRORS OR ALARMS RELATED TO THE COMPLAINT, ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST THE PUMP PASSED THE TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER, A NEW PUMPER, CONTACTED ANIMAS AND ALLEGED THAT SHE HAD BEEN EXPERIENCING BLOOD GLUCOSE (BG) ELEVATIONS FOR PAST 2 DAYS WITH NO REASON FOUND. HER BG ROSE TO 454MG/ DL YESTERDAY, WITH CHEST PAIN AND SHORTNESS OF BREATH. SHE CHANGED OUT SITE/SET/CARTRIDGE, CORRECTED VIA SYRINGE AND BG RESPONDED, DROPPING TO 188MG/DL BY 5PM. HER BGS REMAINED STABLE FOR THE REMAINDER OF THE DAY YESTERDAY. THIS MORNING, BG WAS 85MG/DL. PATIENT BOLUSED APPROPRIATELY FOR BREAKFAST BUT BG ROSE TO 405MG/DL AT 10:54AM. SHE CORRECTED VIA THE PUMP AND BGS WERE 125MG/DL BY 1:04PM. THE REPORTER DENIES ANY NEW HEALTH CONDITIONS OR MEDICATIONS. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP AND FOUND NO ISSUES WITH SETTINGS/RATES, AND NO ASSOCIATED ALARMS IN HISTORY. ALL BOLUSES AND BASALS DELIVERED AS PROGRAMMED AND ADD UP CORRECTLY IN TOTAL DAILY DOSE. PUMP PROPERLY PRIMED; NOT SUSPENDED. CTS ADVISED PATIENT THERE IS NOTHING TO INDICATE A MALFUNCTION WITH PUMP OR INFUSION SET, AND TO CONSULT HER HEALTH CARE PROVIDER. NO PRODUCT ISSUE WAS IDENTIFIED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA. USE ERROR CANNOT BE DISCOUNTED AS CONTRIBUTING TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18851 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening