BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2200013 · Received August 10, 2011

    Report

    Report Number
    2531779-2011-05756
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THE PUMP HISTORY SHOWED THAT THE ACTIVE BASAL PROGRAM WAS 00:00 1 UNIT/HOUR, 10:00 1 UNIT/HOUR. NO ACTIVITY OUTSIDE NORMAL USE WAS RECORDED IN THE BLACK BOX OR DOWNLOAD HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP DID NOT CHANGE BASAL RATES DURING TESTING. NO INSULIN DELIVERY DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD ELEVATED BLOOD GLUCOSE (BG) ON TWO DAYS; SHE SAID THAT HER BG WAS 500MG/DL ON (B)(6) 2011 AND 650MG/DL ON (B)(6) 2011. THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE DELIVERED INSULIN VIA INJECTION AND THE BG DID NOT RESPOND AS EXPECTED. SHE SAID THAT SHE CHANGED TO A NEW BOTTLE OF INSULIN AND STATED THAT BY THE EVENING HER BG CAME DOWN TO 188MG/DL. ON (B)(6) 2011 SHE TREATED THE ELEVATION WITH A SYRINGE OF INSULIN AND REPORTED HER BG WAS 213MG/DL AT THE TIME OF THE CALL. THE PATIENT DENIED SYMPTOMS OF HYPERGLYCEMIA (NAUSEA, EMESIS, SHORTNESS OF BREATH, OR CHEST PAIN) BUT SAID THAT SHE WAS VERY TIRED AND HER CHEST FELT HEAVY. ON (B)(6) 2011, THE PATIENT REPORTED THAT THE BASAL RATES IN THE PUMP WERE INCORRECT. THE PATIENT REPORTED THAT HER USUAL BASAL DELIVERY TOTAL SHOULD BE AROUND 27 UNITS PER DAY. SHE STATED THAT SEVERAL DAYS AGO SHE NOTICED THAT THE BASAL RATE DELIVERY WAS PROGRAMMED FOR AROUND 17 UNITS PER DAY. THE PATIENT SAID THAT ON (B)(6) 2011 SHE INCREASED THE RATES SO THAT THE TOTAL BASAL DELIVERY SHOULD NOW BE AROUND 24 UNITS PER DAY. SHE NOTED THAT SHE WAS ON VACATION AND DOES NOT KNOW THE SPECIFICS OF HER BASAL RATE PROGRAM. CUSTOMER SUPPORT REVIEWED THE BASAL RATE DELIVERY HISTORY WITH THE PATIENT AND FOUND THAT BETWEEN (B)(6) 2011 AND (B)(6) 2011 THE BASAL DELIVERY WAS 19.25 TO 19.60 UNITS PER DAY. THE PATIENT RESPONDED THAT SHE GUESSED IT WAS REALLY AROUND 19 UNITS PER DAY AND NOT 17 UNITS PER DAY AS PREVIOUSLY REPORTED. THE PATIENT DENIED THAT SHE CHANGED THE BASAL RATE SETTINGS, CONFIRMED THAT THERE WAS NO LEAKAGE OF INSULIN AT THE SKIN SITE, AND NOTED THAT SHE HAD NOT REPLACED THE INFUSION SET. WHEN SHE REMOVED THE INFUSION SET SHE NOTED THAT THE CANNULA WAS SLIGHTLY BENT AT THE TIP. THE PATIENT ALLEGED THAT THE BASAL RATE WAS PROGRAMMED WITHOUT USER INTERVENTION AND THAT THE INCORRECT BASAL RATE DELIVERY WAS RESPONSIBLE FOR THE BG ELEVATION.

    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 73 YR Life Threatening