BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173562 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05171
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 24, 2011
    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

    FOLLOW-UP #1 (B)(6) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED THAT ON (B)(6) 2011 AT 2:19 PM A "PUMP NOT PRIMED" WARNING OCCURRED; THE PUMP HISTORY INDICATED THAT THE INSULIN DELIVERY WAS NOT RESUMED UNTIL (B)(6) 2011 AT 6:23 PM. THE PUMP SHOWED MULTIPLE "EXCEEDS MAX BASAL" WARNINGS OCCURRED ON (B)(6) 2011 AT 8:17 PM; THE PUMP DELIVERY WAS NOT RESUMED UNTIL (B)(6) 2011 AT 12:02 AM. DURING TESTING THE PUMP SUCCESSFULLY COMPLETED THE REWIND, LOAD, AND PRIME. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. AN "EXCEEDS MAX BASAL" ALARM WAS DUPLICATED DURING TESTING AND THE PUMP ALARMED WITH APPROPRIATE AUDIBLE AND VISUAL ALERTS. THE FORCE SENSOR WAS TESTED AND WAS FOUND TO BE DETECTING THE CORRECT AMOUNT OF FORCE. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT.

    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

    THE PATIENT CLAIMED HE RECEIVED MEDICAL INTERVENTION FOR A BLOOD GLUCOSE RESULT OF "680 MG/DL" AFTER THE ANIMAS PUMP LOST POWER. THE PATIENT HAD SYMPTOMS DESCRIBED AS "KETONES, NAUSEA AND VOMITING" AT THE TIME OF CONCERN. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2011 WHERE HE SPENT (B)(6) IN THE ICU. REPORTEDLY, THE PATIENT WAS PUT ON AN INSULIN IV DRIP. DURING TROUBLESHOOTING, THE PATIENT NOTED THAT THE ANIMAS PUMP DID NOT RETAIN THE DATE AND TIME. THE POWER ISSUE WAS FROM 6PM TO 6:30 PM ON (B)(6) 2011. ALTHOUGH THERE WAS A POWER ISSUE ON (B)(6) 2011, THE PUMP HISTORY SHOWS BOLUS AND BASAL INSULIN DOSES WAS DISPENSE ACCORDINGLY PRIOR TO AND AFTER THE POWER ISSUE. ON (B)(6) 2011, THE TOTAL DAILY DOSE FOR BOLUS AND BASAL INSULIN WERE 19.45 U AND 43.485 U RESPECTIVELY. THE PATIENT COULD NOT CONFIRM WHETHER THE BASAL SEGMENT WAS CORRECT AS HE DID NOT HAVE THE INFORMATION. THERE IS NO PRODUCT MISUSE. NO ISSUES WERE FOUND WITH INSULIN SITE, CARTRIDGE, AND THE INFUSION SET. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND RECEIVED MEDICAL INTERVENTION FOR ELEVATED BLOOD GLUCOSE AFTER THE PRODUCT ISSUE BEGAN.

    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 47 YR Hospitalization| L| R