BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3161596 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08049
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE PATIENT REPORTED BEING DIAGNOSED WITH PNEUMONIA AND WAS BEING TREATED WITH ANTIBIOTICS WHICH CAN EFFECT THE PATIENT'S BLOOD GLUCOSE LEVELS. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THAT THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE RECORDED ON (B)(6) 2013. THE BLACK BOX SHOWS THE PUMP WAS NOT IN USE BETWEEN (B)(6) 2013, 21:13 AND (B)(6) 2013, 08:17. THE TOTAL DAILY DOSES CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF DISCOLORATION. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE TIME AND DATE RESET TO THE FACTORY SETTINGS. THE PUMP WAS OPENED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. THE ISSUE OF INACCURATE DELIVERY OF INSULIN WAS DUPLICATED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A HOSPITALIZATION FOR BLOOD GLUCOSE LEVELS BETWEEN 500 AND 600 MG/DL WITH NAUSEA AND VOMITING. THE PATIENT STATED THAT THE HOSPITALIZATION WAS FOR THE BLOOD GLUCOSE LEVELS BUT THE PATIENT WAS DIAGNOSED WITH PNEUMONIA. THE PATIENT INDICATED THAT THE HEALTH CARE PROVIDER AT THE HOSPITAL FELT THAT THE PUMP WAS NOT WORKING OR DELIVERING CORRECTLY. THE PATIENT STATED THAT THE PUMP WAS REMOVED AND TREATMENT WAS BEING PROVIDED WITH INJECTIONS AND BLOOD GLUCOSE LEVELS WERE DECREASING. THE PATIENT REPORTED ALSO BEING TREATED WITH INTRAVENOUS ANTIBIOTICS AND FLUIDS. THE PATIENT CONFIRMED THAT THERE WERE NO PROBLEMS WITH AIR BUBBLES IN THE PUMP AND THE PUMP WAS PRIMED UNTIL DROPS WERE SEEN AT THE END OF THE TUBING. THE PATIENT INDICATED THAT THE SITE INSERTION WAS CORRECT AND ALL OF THE CONNECTIONS WERE TIGHT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH THE INDICATION FROM A HEALTH CARE PROFESSIONAL THAT THE PUMP MAY NOT HAVE BEEN DELIVERING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262494 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L