BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233017 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06441
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON THE AFTERNOON OF (B)(6) 2011, THE PATIENT'S INFUSION SITE WAS ACCIDENTALLY PULLED OUT AT WORK AT 1 PM. THE PATIENT'S BLOOD GLUCOSE WAS IN THE NORMAL RANGE OF 125 MG/DL AT THE TIME OF CONCERN. THE PATIENT DID NOT ATTACH THE PUMP TO THE INFUSION SITE UNTIL 3:30 PM WHEN SHE GOT HOME FROM WORK. HER BLOOD GLUCOSE REMAINED ELEVATED AT 400 MG/DL EVEN THOUGH SHE CHANGED THE SITE AND TOOK BOLUS INSULIN. THE LAST BOLUS INSULIN THE PATIENT TOOK WAS AT 5:30 PM WHEN HER BLOOD GLUCOSE WAS ELEVATED TO 500 MG/DL. THE PATIENT'S INFUSION SITE AND INSULIN CARTRIDGE WAS CHANGED AT 8:37 PM. REPORTEDLY, THE PATIENT DID NOT CHECK HER BLOOD GLUCOSE OR TAKE ANY MORE BOLUS INSULIN UNTIL THE NEXT DAY. ON (B)(6) 2011 AT 8:30 AM, THE PATIENT ALLEGEDLY WAS VOMITING AND TESTED AT 500 MG/DL. THE PATIENT CHANGED THE INFUSION SITE AGAIN AT 10:05 AM; HOWEVER, HER BLOOD GLUCOSE REMAINED AT 500 MG/DL ALL DAY. WITH SEVERAL BOLUSED INSULIN DOSE VIA THE SUBJECT PUMP AND VIA THE SYRINGE, THE PATIENT'S BLOOD GLUCOSE CAME DOWN TO 380 MG/DL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENT'S ALLEGED ELEVATED BLOOD GLUCOSE BY EVALUATING THE ANIMAS PUMP. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE. THE DATE AND TIME WERE CONFIRMED TO BE ACCURATE. THERE WERE NO ISSUES SUCH AS LEAKAGE AND AIR BUBBLES WITH THE INFUSION SET. HOWEVER, THE PATIENT REPORTEDLY HAD AIR BUBBLES IN THE CARTRIDGE WHEN THE INFUSION SITE ACCIDENTALLY CAME OFF. THERE WERE NO AIR BUBBLES IN THE CARTRIDGE AFTER THE PATIENT CHANGED THE INFUSION SITE. THERE WAS NO SIGN OF A KINK OR BENDING OF THE CANNULA AT THE INFUSION SITE. THE PATIENT REPORTEDLY WAS ABLE TO PRIME SUCCESSFULLY WITH ANIMAS PUMP. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THE ANIMAS PUMP WILL NOT BE RETURNED FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USER ERROR AND BECAUSE THE PATIENT ALLEGEDLY WAS HYPERGLYCEMIC AND HAD SYMPTOMS SUGGESTIVE OF ACUTE COMPLICATION OF DIABETES WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS PUMP.

    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 53 YR Life Threatening| R