BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021435 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03077
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/07/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND NO COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND THE CURRENT DATE RANGE DID NOT COVER THE COMPLAINT DATE DUE TO CUSTOMER CONTINUED USE. REVIEW OF THE CURRENT DATE RANGE DID NOT FIND ANY WARNINGS OR ALERTS RELATED TO THE COMPLAINT AND THE TOTAL DAILY DELIVERIES ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL SETTINGS. THE BATTERY AND CARTRIDGE CAP WERE RETURNED AND USED IN THE INVESTIGATION. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUE WAS OBSERVED WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS. BOLUS EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE INVESTIGATION WAS UNABLE TO VERIFY THE REPORTED ISSUE IN THE BLACK BOX OR DUPLICATE THE COMPLAINT. UNRELATED TO THE REPORTED ISSUE, THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED FROM THE TOP TO THE GRIP PAD. IN ADDITION, THE FORCE SENSOR CALIBRATION WAS FOUND LOW OUT OF SPECIFICATIONS WHILE THE FORCE SENSOR RESISTANCE READING WAS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT HIS BLOOD GLUCOSE (BG) WAS 377 MG/DL LAST NIGHT AND HE BOLUSED VIA EZBG, APPROXIMATELY 27 UNITS. HE WOKE UP WITH BG 44 MG/DL AT 2 AM AND FOLLOWED RULE OF 15S. AT 5 AM, BG WAS 39MG/DL AND HE ATE ½ MEAT SANDWICH AND 15 G OF SUGARED SODA AND TWO CHOCOLATE CHIP COOKIES, NO BOLUS. AT 8 AM BG WAS 77 MG/DL. PATIENT CONTACTED HEALTH CARE PROVIDER (HCP) AND WAS INSTRUCTED TO DO A TEMPORARY BASAL -50% FOR 6 HOURS. STATES BG HAS CURRENTLY DROPPED TO 60 MG/DL. THE PATIENT REPORTS HIS A1C HAS DECREASED FROM 8.9% TO 6.7%, BUT DENIES RECENT CHANGES IN IC RATION OR ISF. CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED PATIENT TO SUSPEND PUMP. PATIENT STATES THIS IS THE FIRST TIME HE HAS SUSPENDED SINCE EXPERIENCE LOWS. CTS REVIEW FOUND NO ASSOCIATED ALARMS NOTED IN ALARM HISTORY BOLUS HISTORY: NO CANCELLED BOLUSES AND ALL BOLUSES ARE ACCOUNTED FOR BASAL HISTORY: CONFIRMED BASAL DELIVERY WAS APPROPRIATE PRIME HISTORY: PATIENT HAS BEEN PRIMING PROPERLY/ DROPS SEEN AT THE END OF THE TUBING AND HE CHANGES SUPPLIES EVERY 3 DAYS OR SOONER IF HIGH BG IS PRESENT. SUSPEND HISTORY: NO INADVERTENT SUSPENDS NOTED. TOTAL DAILY DOSE: TDD WAS ACCURATE WHEN COMPARING TO BASAL AND BOLUS HISTORY AND SETTINGS. CTS ADVISED PATIENT TO KEEP PUMP SUSPENDED UNTIL BG IS ABOVE 90 MG/DL AND TO CONTACT HCP AGAIN FOR FURTHER ADVISE. THERE IS NO INDICATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED AS A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPOGLYCEMIA FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123857 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening