BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2893522 · Received January 2, 2013

    Report

    Report Number
    2531779-2013-00077
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: (B)(6) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. ACCORDING THE BLACK BOX, LAST BASAL DELIVERY WAS ON (B)(6) 2012, AT 6:59 PM. THE SUSPEND HISTORY RECORDED PUMP'S SUSPENDS ON: (B)(6) 2012, FOR 2HOURS 30 MINUTES, (B)(6) 2012, FOR 1 HOUR 20 MINUTES, (B)(6) 2012, FOR 1HOUR, AND (B)(6) 2012, FOR 1HOUR. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO CIRCUIT DEFECTS OR INTERMITTENT CONNECTIONS WERE FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED; A TEST DISPLAY WAS INSERTED AND CONFIRMED A NORMAL DISPLAY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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)2012, THE PATIENT'S FIANCÉE CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PATIENT HAS EXPERIENCED BLOOD GLUCOSE (BG) LEVELS FROM 300 TO "HI" MG/DL WITH NAUSEA/VOMITING OVER PAST 4 DAYS. HE STATES THE INFUSION SET HAS BEEN CHANGED 4 TIMES IN THE PAST 2 DAYS, WITH NO EVIDENCE OF A BENT/KINKED CANNULA; NO REDNESS OR IRRITATION AT SITE, AND NO SCAR TISSUE. THE PATIENT IS CORRECTING HIGH BG WITH A SYRINGE. SITES ARE REPORTEDLY ROTATED WELL. NO LEAKING IN TUBING OR CARTRIDGE . THE PATIENT DISCONNECTED FROM THE PUMP, REMOVED CURRENT CARTRIDGE AND NO EVIDENCE OF AIR BUBBLES WAS SEEN. TWO BIG AIR BUBBLES WERE REPORTEDLY NOTED YESTERDAY IN TUBING: THE PATIENT DISCONNECTED AND REPRIMED. THE PATIENT IS USING REFRIGERATED INSULIN BUT REMOVES IT FROM THE REFRIGERATOR 10-20 MINUTES BEFORE FILLING CARTRIDGE. THE PATIENT IS VISUALLY IMPAIRED, HAVING HAD EYE SURGERY ABOUT 10 WEEKS AGO. HER FIANCÉE DOES THE SITE CHANGES, FILLS CARTRIDGES, AND ASSISTS WITH PUMP FUNCTION. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED FIANCÉE AFTER TROUBLESHOOTING THAT THERE WAS NO INDICATION OF A PUMP MALFUNCTION. CONTRIBUTING FACTORS TO THE HIGH BG ARE LIKELY THE AIR BUBBLES SEEN IN THE TUBING YESTERDAY, IN ADDITION TO TIMES WHEN PUMP WAS SUSPENDED IN EXCESS OF 1HOUR: SUSPENSIONS WERE INTENTIONAL AND THE PATIENT DOES THIS REGULARLY. THE FIANCÉE AGREES WITH THIS ASSESMENT, HOWEVER, BELIEVES THAT PUMP IS STILL MALFUNCTIONING AND NOT DELIVERING AMOUNTS PROGRAMMED. HE STATES AIR BUBBLES WERE ONLY FOUND ON 1 OCCASION AND THAT DOES NOT EXPLAIN A 4 DAY ELEVATION. THE FIANCÉE STATES HE DELIVERED A 9U AIR BOLUS AND CAUGHT VOLUME IN A TEASPOON AND THEN COMPARED 9U FROM A SYRINGE IN ANOTHER TEASPOON AND SAYS THE VOLUMES WERE VASTLY DIFFERENT. THE PATIENT AND HER FIANCÉE HAVE LOST FAITH IN THIS PUMP, AND STATE THEY HAVE CONTACTED A DIABETES EDUCATOR WHO AGREED THAT THE PUMP IS NOT DELIVERING CORRECTLY. BACKUP PLAN IS IN PLACE AND BEING IMPLEMENTED UNTIL A NEW PUMP ARRIVES. THE NEW PUMP WILL BE A COLOR THAT THE PATIENT WILL BE ABLE TO SEE AS HER SEVERE VISUAL IMPAIRMENT MAKE IT DIFFICULT FOR HER TO SEE A BLACK PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA WITH NAUSEA AND VOMITING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening