BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2914363 · Received January 14, 2013

    Report

    Report Number
    2531779-2013-00619
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. THE USER GUIDE INSTRUCTS THE PATIENT TO DISCONNECT PRIOR TO PERFORMING PRIME STEPS; ADDITIONALLY, THE PUMP DISPLAYS A WARNING MESSAGE WHEN ENTERING THE PRIME MENU TO REMIND THE USER TO DISCONNECT FROM THE SITE. NO CONCLUSIONS CAN BE MADE AT THIS TIME. SUSPECTED MEDICAL DEVICE SERIAL #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING MULTIPLE LOSS OF PRIME WARNINGS RESULTING IN TWO BLOOD GLUCOSE EXCURSIONS. ON THE FIRST OCCASION, THE PATIENT REPORTED SLEEPING THROUGH THE LOSS OF PRIME ALARM DURING THE NIGHT AND BLOOD GLUCOSE LEVELS IN THE MORNING WERE 22MMOL/L WITH MEDIUM KETONES. THE PATIENT REPORTED CORRECTING THE BLOOD GLUCOSE AFTER WAKING IN THE MORNING. ON A SECOND OCCASION, THE PATIENT REPORTED FORGETTING TO DETACH FROM THE SITE WHEN PRIMING THE TUBING RESULTING IN A BLOOD GLUCOSE OF 1.8 MMOL/L WITH UNRESPONSIVENESS. THE PATIENT WAS REPORTEDLY TREATED WITH GLUCAGON AND GLUCOSE TABS AND BLOOD GLUCOSE LEVELS RESOLVED TO 6 MMOL/L. THE PATIENT CONFIRMED THAT THERE WERE NO KNOWN POWER ISSUES WITH THE PUMP, THERE WERE NO RELATED ALARMS, AND THERE WAS NO KNOWN EXPOSURE TO EXTREME TEMPERATURES. THE PATIENT WAS ADVISED TO TRY CHANGING THE CARTRIDGE TO SEE IF THE ISSUE RESOLVES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPER AND HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20930 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening