BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6489426 · Received April 13, 2017

    Report

    Report Number
    2531779-2017-07624
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    March 17, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/24/2017 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX INDICATED NO ABNORMAL PUMP BEHAVIOR. PUMP HISTORY SHOWS THE PUMP WAS NOT IN USE BETWEEN (B)(6) 2017 14:01 UNTIL (B)(6) 2017 12:29. THE BLACK BOX SHOWS AN AUTO OFF ALARM ON (B)(6) 2017 23:02; DELIVERIES RESUMED (B)(6) 2017 12:28. AN UNEXPLAINED REBOOTING EVENT OCCURRED ON (B)(6) 2017 10:13; DELIVERIES RESUMED AT 10:41. A REPLACE CARTRIDGE ALARM WAS RECORDED ON (B)(6) 2017 20:49; DELIVERIES RESUMED AT 21:19. THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2017 09:19 AND WAS MANUALLY RESUMED AT 13:13. ON (B)(6) 2017 22:31 AUTO OFF ALARM OCCURRED; DELIVERIES RESUMED ON (B)(6) 2017 02:01. AN UNEXPLAINED REBOOTING EVENT OCCURRED ON (B)(6) 2017 10:32; WHEN THE PUMP WAS POWERED BACK ON THE TIME/DATE WAS SET INCORRECTLY TO (B)(6) 2017 00:04 AND DELIVERIES RESUMED. ON (B)(6) 2017 20:56 AN EXCEEDS-MAX-TDD-LIMIT ALARM WAS RECORDED FOLLOWED BY A REBOOTING EVENT AT 21:05; DELIVERIES RESUMED ON (B)(6) 2017 12:08. THE TOTAL DAILY DOSE HISTORY WAS APPROPRIATE FOR THE USER PROGRAMMED DELIVERY SETTINGS. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. TWO BATTERY COMPARTMENT CRACKS WERE OBSERVED. NO POWER ISSUES WERE EXPERIENCED DURING TESTING. THE DISPLAY WAS DIM AND DISCOLORED. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2017 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 32 MG/DL. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPOGLYCEMIA AND NO FURTHER DETAILS WERE PROVIDED. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF INITIAL CONTACT. CUSTOMER TECHNICAL SUPPORT MADE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271792 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening