BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213068 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05926
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORY. A REVIEW OF THE PUMP'S ALARM HISTORY INDICATED THAT MULTIPLE LOW CARTRIDGE WARNINGS AND EMPTY CARTRIDGE ALARMS HAD OCCURRED. THE REMAINING INSULIN READING WAS ACCURATELY CALCULATED DURING TESTING: THE PUMP WAS PRIMED UNTIL 20 UNITS REMAINED IN THE CARTRIDGE, AT WHICH POINT THE PUMP EMITTED A LOW CARTRIDGE WARNING. THE CARTRIDGE WAS REMOVED FROM THE PUMP AND INVESTIGATORS VISUALLY CONFIRMED THAT THERE WERE 20 UNITS REMAINING IN THE CARTRIDGE. THERE WAS NO DEFECT FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE OF 28 MMOL/L WITH NAUSEA AND VOMITING; THE PATIENT REPORTEDLY WENT TO A CLINIC WHERE SHE WAS GIVEN MEDICATION FOR NAUSEA AND THE DOCTOR FOUND THAT THE CARTRIDGE IN THE PUMP WAS EMPTY. THE PATIENT REPORTED THAT THE PUMP DID NOT ALARM FOR AN EMPTY CARTRIDGE. THE PATIENT REPORTEDLY CHANGED TO A NEW CARTRIDGE, TUBING, AND INSERTION SITE AND HER BG RESOLVED. THE PATIENT CONFIRMED THAT THERE WERE NO ALARMS ON THE SCREEN AT TIME OF EMPTY CARTRIDGE; THE PUMP STILL HAD POWER AND APPEARED TO BE DELIVERING NORMALLY. THE PATIENT REPORTED THAT SINCE THE EVENT, THE PUMP WAS FUNCTIONING NORMALLY. THE PATIENT CONFIRMED THAT SINCE THE EVENT THE PUMP WAS ALARMING LOW CARTRIDGE APPROPRIATELY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AFTER THE PUMP FAILED TO ALARM FOR AN EMPTY CARTRIDGE.

    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 47 YR Required Intervention