BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181769 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08722
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 ANIMAS RECEIVED ADDITIONAL INFORMATION FROM THE PATIENT. THE PATIENT HAD ORIGINALLY REPORTED EXPERIENCING A LOW BG OF 23 MG/DL WHILE ON A BACK-UP PLAN FOR INSULIN DELIVERY. FOLLOW-UP INFORMATION INDICATED THAT THE PATIENT REMAINED ATTACHED TO THE PUMP AND WAS DELIVERING INSULIN BY MANUALLY PUSHING SMALL AMOUNTS OF INSULIN THROUGH THE CARTRIDGE AND SUBSEQUENTLY EXPERIENCED THE REPORTED LOW BG.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY CAP RETURNED WITH THE PUMP WAS COMPLETELY DAMAGED. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION; THE TEST CAP WAS ABLE TO SECURE APPROPRIATELY TO THE PUMP WITH NO ISSUES. VISUAL INSPECTION FOUND NO DAMAGE TO THE BATTERY COMPARTMENT. A REVIEW OF THE BLACK BOX SHOWED NO ACTIVITY OUTSIDE NORMAL USE EXCEPT FOR A 5 HOUR BASAL DELIVERY INTERRUPTION ON (B)(6) 2013, WHICH WAS DETERMINED TO BE A RESULT OF AN UNACKNOWLEDGED ALARM. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP POWERED ON APPROPRIATELY TO THE VERIFY SCREEN. THE PUMP WAS PRIMED SUCCESSFULLY AND WAS EXERCISED FOR 24 HOURS ON A 1UNIT PER HOUR BASAL RATE, WITH NO POWER INTERRUPTIONS OCCURRING. THE PUMP WAS EXERCISED FOR 29 HOURS ON A FLOW ACCURACY TEST WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT AFTER COMING OFF THE PUMP ON (B)(6) 2013, DUE TO BATTERY CAP AND BATTERY COMPARTMENT DAMAGE, SHE WENT TO THE ER FOR HYPOGLYCEMIA. THE PATIENT REPORTED THE FOLLOWING SEQUENCE OF EVENTS. THE PATIENT WAS REPORTEDLY PERFORMING A ROUTINE BATTERY CHANGE ON (B)(6) 2013, WHEN THE BATTERY CAP FELL APART. THE PATIENT REPORTEDLY CAME OFF THE PUMP AND WENT ON A BACK-UP PLAN FOR INSULIN DELIVERY. THE PATIENT REPORTEDLY ATTEMPTED TO USE A BORROWED BATTERY CAP, BUT WAS UNABLE TO ATTACH THE BATTERY CAP AND THEN NOTICED THAT THE BATTERY COMPARTMENT THREADS DID NOT LOOK NORMAL. THE PATIENT DENIED ANY POWER LOSS PRIOR TO NOTICING THE DAMAGE. WHILE ON THE BACK-UP PLAN, THE PATIENT STATED SHE EXPERIENCED A LOW BG OF UNKNOWN VALUE; THE PATIENT BELIEVED HER BG WAS LESS THAN 23MG/DL. THE PATIENT DENIED SYMPTOMS OF LOW BG. THE PATIENT REPORTED THAT SHE WAS TREATED FOR THE LOW BG AND RELEASED; SPECIFICS OF TREATMENT WERE NOT PROVIDED. THE PATIENT REPORTED THAT SHE DOES NOT EXPERIENCE SIGNS OR SYMPTOMS WITH LOW BGS. THE PATIENT¿S BG AT THE TIME OF THE CALL TO ANIMAS WAS REPORTEDLY 318MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PUMP WAS REPLACED DUE TO THE DAMAGED BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA REQUIRING MEDICAL INTERVENTION AFTER COMING OFF THE PUMP DUE TO A PUMP DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283506 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R