BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223496 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10502
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 05/02/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/22/2014 WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.THE BLACK BOX BEGINS ON 03/20/2014. THE CURRENT PUMP HISTORY SHOWS NO ALARMS RELATED TO THE COMPLAINT; ONLY TYPICAL USAGE WAS OBSERVED. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. A FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 LBS. REMOVED PUMP COVER AND FORCE SENSOR; FORCE SENSOR RESISTANCE IS IN SPECIFICATION. NO EVIDENCE OF CONTAMINATION FOUND IN FORCE SENSOR HOUSING. 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 STATING ON THE MORNING OF (B)(6) 2013 WHEN THE PATIENT AWOKE, THE PATIENT EXPERIENCED CONFUSION, DIARRHEA, SEVERE MUSCLE ACHES, ABDOMINAL PAIN, CRAMPS, DRY MOUTH AND FREQUENT URINATION. THE REPORTER REPORTEDLY CALLED 911 AND UPON ARRIVAL TO THE HOSPITAL, THE PATIENT¿S BLOOD GLUCOSE (BG) REPORTEDLY WAS OVER 600 MG/DL. THE PATIENT REPORTEDLY WAS DISCONNECTED FROM PUMP BY THE HOSPITAL STAFF AND WAS TREATED VIA INTRAVENOUS INSULIN DRIP. THE PATIENT¿S BG REPORTEDLY DECREASED TO 200 MG/DL TO 300 MG/DL RANGE AFTER TREATMENT. IT WAS NOTED THAT THE PATIENT¿S BG WAS 300 MG/DL THE NIGHT BEFORE THE REPORTED EVENT AND HAD EXPERIENCED UNEXPLAINABLE HIGH BGS IN THE RANGE OF 300 MG/DL TO 600 MG/DL FOR A MONTH. IT WAS NOTED AT TIMES, THE PATIENT FELT TIRED AND NAUSEATED. THE PATIENT REPORTEDLY USED THE SAME SITES AND ROTATED THEM AROUND. THE PATIENT DENIED HAVING ISSUES WITH THE SITE/SET OR CARTRIDGE. THE PATIENT DENIED CHANGES IN MEDICATION. IT WAS NOTED THAT THE PATIENT FELT THAT SHE WAS COUNTING HER CARBOHYDRATES CORRECTLY. THE PATIENT REPORTEDLY HAD GASTROENTERITIS AND KIDNEY DISEASE BUT WAS NOT ON DIALYSIS. THE PATIENT REPORTEDLY DISCONTINUED INSULIN PUMP THERAPY AND IS WORKING WITH THE HEALTH CARE PROVIDER (HCP) TO CONTROL THE HIGH BG ISSUE. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY; NO ISSUES WERE NOTED WITH THE PROGRAMMING/SETTINGS ON THE PUMP; THE PUMP WAS FOUND TO BE DELIVERING WITH NO ISSUES. THERE WERE NO INDICATION OF A PUMP MALFUNCTION; THE PUMP REPORTEDLY IS BEING RETURNED. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS UNCLEAR WHAT THE CONTRIBUTING CAUSE WAS FOR THE PATIENT¿S HIGH BG ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323633 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R