BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2082996 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03270
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1, DATE OF SUBMISSION 06/23/2011 - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/26/2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXERCISED FOR A MINIMUM OF 24 HOURS AND THERE WERE NO ALARMS OR INADVERTENT INFUSIONS WERE OBSERVED. THE PUMP DELIVERED THE ACCURATE PROGRAMMED BASAL RATE FOR 24 HOUR DURATION. THE PUMP WAS TESTED ON A 2 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING ACCURATELY. THE DAILY INSULIN DELIVERY TOTALS RECORDED IN THE PUMP HISTORY CORRECTLY REFLECT THE PROGRAMMED BASAL RATES. THERE WAS NO DEFECT FOUND WITH THE PUMP. DHR REVIEW, DATE OF MANUFACTURE 2010-04, SOFTWARE VERSION / REVISION E3A, WITHIN SPECIFICATIONS WHEN RELEASED YES.

    Additional Manufacturer Narrative · 1

    (B)(4): THIS COMPLAINT IS BEING RECLASSIFIED FROM A MALFUNCTION TO ADVERSE EVENT FOR FOLLOWING REASON: THE PATIENT WAS TREATED BY AN HCP AFTER THE ALLEGED PUMP ISSUE OCCURRED.

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE PUMP DISPENSED INSULIN WITHOUT KNOWN USER INTERVENTION. THE PATIENT REPORTED THAT A LOUD, SCREECHING SOUND COMING FROM THE PUMP WOKE HIM UP. HE SAID THAT HE DISCONNECTED FROM THE INFUSION SET AND SAW INSULIN FLOWING FROM THE END OF THE TUBING. THE PATIENT NOTED THAT THE DISPLAY SCREEN SAID "LOCKED" AND HE CONFIRMED THAT HE LOCKS THE PUMP AT NIGHT. A SHORT TIME LATER THE SCREECHING NOISE STOPPED AND THE PUMP CONTINUED TO SOUND AS IF IT WERE COMPLETING THE REWIND STEP. THE PATIENT REPORTED THAT THE LOWER HALF OF THE SCREEN THEN DISPLAYED A SINGLE HORIZONTAL YELLOW BAR, BEEPED ONCE, AND THEN DISPLAYED A BLANK SCREEN WITH NO TONES PRESENT. HE STATED THAT ABOUT 10 TO 20 MINUTES LATER THE PUMP BEEPED ONCE AGAIN AND THE SCREEN WAS BLANK WITH NO TONES. A FAMILY MEMBER STATED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 270 MG/DL AT THE TIME OF THE EVENT. THE PATIENT STATED THAT THE CARTRIDGE EMPTIED ABOUT 160 UNITS; HE WAS UNCERTAIN HOW MUCH OF THAT INSULIN HE RECEIVED. HE BEGAN TO TREAT HIMSELF WITH ORAL CARBOHYDRATES, WENT TO THE HOSPITAL, AND HIS BG WAS TESTED AT 490 MG/DL AT THE EMERGENCY ROOM. THEY MONITORED HIS BG FOR 4 TO 5 HOURS; THEY TREATED HIM WITH SALINE INTRAVENOUS FLUIDS AND SUBCUTANEOUS INJECTIONS OF INSULIN. HE SAID THAT HE DOES NOT RECALL HIS BG VALUE WHEN HE LEFT THE HOSPITAL BUT SAID HE DID NOT EXPERIENCE ANY LOW BG VALUES. THE PATIENT STATED THAT HIS PHYSICIAN PLACED HIM ON INJECTIONS FOR INSULIN DELIVERY AND INSPECTED THE PUMP. THE PHYSICIAN TOLD HIM THAT THERE WERE NO VISUAL DEFECTS AND THAT THE PISTON APPEARED TO BE IN A FULLY REWOUND POSITION. THE PATIENT REPORTED THAT HIS LAST CARTRIDGE REPLACEMENT WAS 2 DAYS AGO WITHOUT INCIDENT; THE LAST ALARM WAS A LOW CARTRIDGE WARNING 4 DAYS AGO. THIS COMPLAINT IS BEING REPORTED BECAUSE THE CAUSE OF THE INSULIN DISCHARGE REMAINS UNKNOWN. ALTHOUGH THE PATIENT WAS MONITORED IN THE HOSPITAL FOR POSSIBLE HYPOGLYCEMIA, THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization