BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2222298 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06199
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE WAS OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE BLACK BOX AND BOLUS HISTORY VERIFIED A 10.55 UNIT BOLUS OCCURRING AT 4:55 PM ON (B)(6) 2011. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS WITH NO UNPROGRAMMED BOLUSES OCCURRED DURING TESTING. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD WAS REMOVED AND NO HYPERSENSITIVE OR DEFECTIVE BUTTON CONTACTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT AND A NURSE CONTACTED ANIMAS ALLEGING AN INADVERTENT INFUSION OF INSULIN. THE PATIENT WAS SENT A LETTER SINCE THE ANIMAS MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO CONTACT THE PATIENT VIA TELEPHONE FOR FOLLOW-UP INFORMATION. THE PATIENT REPORTED THAT SHE HAD SUFFERED A HYPOGLYCEMIC EVENT AT 2:00 AM ON (B)(6) 2011. AT THAT TIME, THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE (BG) LEVEL WAS "29 MG/DL" AND SHE HAD SYMPTOMS OF SHAKINESS, DIFFICULTY WALKING, AND TROUBLE FOCUSING WITH HER VISION. SHE TREATED HERSELF WITH A GRANOLA BAR AND JUICE. BY 2:12 AM THAT SAME MORNING, THE PATIENT CLAIMED THAT HER BG LEVEL WENT UP TO "212 MG/DL." DUE TO THINKING THAT SHE OVER-CORRECTED, THE PATIENT SELF-ADMINISTERED A 4.55 UNIT BOLUS OF INSULIN (UNKNOWN TYPE). WHEN SHE WOKE UP LATER THAT SAME DAY AT AN UNSPECIFIED TIME, THE PATIENT CLAIMED THAT HER BG LEVEL WAS "350 MG/DL." BY 3:00 PM, THE PATIENT THAT SAME DAY, THE PATIENT MENTIONED THAT HER BG WENT DOWN TO "34 MG/DL." THE PATIENT ADMINISTERED TREATMENT BY DRINKING JUICE. BY THE TIME SHE CONTACTED ANIMAS ON (B)(6) 2011, HER BG HAD RISEN TO "96 MG/DL." THE PATIENT HAD NO RATIONALE TO EXPLAIN THE LOW BG EPISODES. WHILE REVIEWING THE PUMP, THE PATIENT CLAIMED THAT ON (B)(6) 2011, AT 4:55 PM, THE PUMP DELIVERED A BOLUS OF "10.55 UNITS" THAT SHE DENIED GIVING HERSELF. THE PATIENT'S LAST BOLUS PRIOR TO THE HYPOGLYCEMIC EVENT AT 2:00 AM THAT MORNING IS UNKNOWN. THE PATIENT DID NOT ALLEGE ANY INADVERTENT INSULIN DELIVERIES PRIOR TO THE REPORTED HYPOGLYCEMIC EVENTS. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP DELIVERED INSULIN THAT SHE DENIED GIVING HERSELF. IN ADDITION, THE PATIENT ALSO REPORTEDLY SUFFERED TO HYPOGLYCEMIC EVENTS WITH SYMPTOMS AND BG VALUES THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY. IT IS UNKNOWN, HOWEVER, AT THIS TIME WHAT FACTORS CONTRIBUTED TO THE PATIENT'S INJURIES.

    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 21 YR Life Threatening| R