BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3492387 · Received November 27, 2013

    Report

    Report Number
    2531779-2013-22384
    Event Type
    Injury
    Date Received
    November 27, 2013
    Date of Event
    November 15, 2013
    Report Date
    November 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 7/06/2017 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE BLACK BOX DATA AND HISTORIES FROM THE TIME OF THE ALLEGED INCIDENT WERE OVERWRITTEN THEREFORE THEY WERE UNAVAILABLE FOR REVIEW DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE INSULIN ON BOARD WAS FOUND TO FUNCTIONING PROPERLY BUT THE PUMP INFORMATION FOR THE COMPLAINT DATE WAS OVERWRITTEN THEREFORE THE INVESTIGATION WAS UNABLE TO DUPLICATE THE INITIAL COMPLAINT ABOUT AN ¿INACCURATE DELIVERY¿ ISSUE. UNRELATED TO THE ORIGINAL COMPLAINT, IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING ON (B)(6) 2013, SHE EXPERIENCED A BLOOD GLUCOSE (BG) IN THE RANGE OF 501 MG/DL TO 509 MG/DL AND WENT TO THE EMERGENCY ROOM. THE PATIENT STATED WHEN SHE CHANGED THE SITE AT 10:00 PM ON (B)(6) 2013; THE BG ELEVATED TO 425 MG/DL AND SHE EXPERIENCED SYMPTOMS OF INCREASED THIRST AND LETHARGY. THE PATIENT REPORTEDLY NOTICED AIR BUBBLES IN THE TUBING AND IN THE CARTRIDGE BUT DID NOT CHANGE OUT THE SUPPLIES OR THE SITE. IT WAS NOTED BY 11:30 PM, THE PATIENT¿S BG ELEVATED TO 501 MG/DL. THE PATIENT REPORTEDLY CONTACTED THE HEALTH CARE PROVIDER (HCP) AND THE HCP ADVISED THE PATIENT TO DISCONNECT FROM THE PUMP, TO TREAT THE BG VIA A 5.0 UNIT CORRECTION INJECTION OF NOVALOG AND GO TO THE EMERGENCY ROOM. THE PATIENT REPORTEDLY REFUSED TO REMOVE THE INFUSION SET AND WHEN IN THE ER, THE PATIENT¿S BG ELEVATED TO 509 MG/DL. THE PATIENT REPORTEDLY WAS TREATED VIA 4.0 UNITS OF INSULIN AND SEVERAL HOURS LATER, THE PATIENT¿S BG DROPPED TO 201 MG/DL. THE PATIENT REPORTEDLY WAS RELEASED FROM THE HOSPITAL AND AT 7 AM, THE NEXT MORNING, THE PATIENT¿S BG WAS 261 MG/DL. THE PATIENT REPORTEDLY HAD GIVEN HERSELF A 4.0 UNIT INSULIN CORRECTION INJECTION OF NOVALOG AT 7:45 AM AND ALSO TREATED WITH 22 UNITS OF LANTUS PER THE RECOMMENDATION OF THE HCP AND AT 9:30 AM, THE PATIENT¿S BG WAS REPORTED TO BE 276 MG/DL. CUSTOMER SUPPORT (CS) REVIEWED THE PATIENT¿S INSERTION TECHNIQUE AND NOTED THAT THE PATIENT HAD STRETCH MARKS AND POSSIBLY SCAR TISSUE AND MAY HAVE BEEN TOO CLOSE TO THAT AREA. THERE WAS NO OTHER INDICATION OF AN INSERTION TECHNIQUE ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVEN WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BASED ON THE FOLLOWING: THE CANNULA WAS BENT, AIR BUBBLES WERE NOTED IN THE CARTRIDGE AND THE TUBING AND THE PATIENT TO CONTINUE TO THE SAME SUPPLIES WITHOUT REPLACING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618348 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R