BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2834478 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13675
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO DEFECT IN INSULIN DELIVERY WAS FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. NO ERRORS OR ALARMS RELATED TO THE COMPLAINT ARE IN THE BLACK BOX OR ALARM HISTORY. THE BLACK BOX SHOW THE PUMP WAS IN USE FROM (B)(4) 2012 14:37 AND THE LAST BASAL DELIVERY WAS ON (B)(4) 2012 AT 16:47. UNRELATED TO THIS COMPLAINT, A FORCE SENSOR CALIBRATION TEST SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 LBS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT A BLOOD GLUCOSE READING OF 507 MG/DL. THE PATIENT REPORTEDLY STARTED ON INSULIN PUMP THERAPY ON (B)(6) 2012. HER NORMAL BLOOD GLUCOSE READING RANGE IS IN THE MID 100S MG/DL. ON (B)(6) 2012, THE PATIENT WAS ELEVATED TO 507 MG/DL. THE PATIENT CLAIMED SHE TOOK BOLUS INSULIN VIA THE PUMP AND WALKED FOR 3 MILES BUT HER BLOOD GLUCOSE READING DID NOT COME DOWN. SHE HAD SYMPTOMS OF NAUSEA. SHE WAS INSTRUCTED TO CHANGE HER INFUSION SITE BUT WAS HAVING A LOT OF TROUBLE IN THE PROCESS. THE PATIENT WAS FRUSTRATED WITH THE INSULIN PUMP THERAPY AND DID NOT WANT TO CONTINUE. SHE DISCONNECTED FROM THE SUBJECT PUMP AT AROUND 4 PM AND IS BACK ON INSULIN VIA SYRINGE. THE PATIENT DECLINED TO REVIEW THE SUBJECT PUMP AND REQUESTED TO RETURN THE SUBJECT PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THERE IS EVIDENCE OF A PUMP MALFUNCTION, THE SUBJECT PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR OF THE INCIDENT.

    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 64 YR Life Threatening