BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3042249 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03824
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 14, 2013
    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

    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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX AND HISTORY WERE REVIEWED. THE BLACK BOX CONTAINS DATES FROM (B)(4) 2013. THERE WERE NO WARNINGS RELATED TO COMPLAINT OBSERVED. ON (B)(4) 2013 AT 23:13 A REPLACE CARTRIDGE ALARM WAS RECEIVED. THE ALARM WAS CONFIRMED AT 23:40 ON (B)(4) 2013. THERE WAS NO EVIDENCE OF PUMP REBOOTS OBSERVED BEFORE OR AFTER THE REPLACE CARTRIDGE ALARM. THE PUMP HISTORY VERIFIED THAT THE PUMP WAS DELIVERING THE PROGRAMMED BASAL RATE PRIOR TO THE CARTRIDGE ALARM ON (B)(4) 2013. DURING EVALUATION, THE PUMP PASSED A LEAK TEST. THE PUMP CASE WAS REMOVED AND THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE PUMP. THE PUMP PASSED 29 HOUR FLOW TEST. THE ORIGINAL ISSUE OF THE PUMP REBOOTING WAS NOT DUPLICATED AND MOISTURE INGRESS COULD NOT BE CONFIRMED DURING INVESTIGATION. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT LAST NIGHT HE WENT TO A POOL PARTY AND WAS PUSHED INTO THE POOL. THE PATIENT REPORTED THAT THE PUMP WAS FUNCTIONING LAST NIGHT BUT WHEN HE WOKE UP THIS MORNING HE NOTICED WATER BEHIND THE DISPLAY SCREEN AND THAT THE PUMP WAS REBOOTING BY ITSELF. THE PATIENT DENIED DAMAGE TO THE PUMP'S CASING, THE KEYPAD WAS INTACT AND THE YELLOW O-RING WAS NOT VISIBLE. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND CLEANS THE PUMP WITH RUBBING ALCOHOL. THE PATIENT STATED THAT HIS BLOOD GLUCOSE (BG) READ HIGH ON THE METER WITH EXTREME POLYURIA AND NEGATIVE FOR KETONES. THIS MORNING AT 6 AM THE PATIENT GAVE HIMSELF 8 UNITS OF HUMOLOG VIA SYRINGE. THREE HOURS LATER THE PATIENT'S BG WENT DOWN TO 180MG/DL. THE PATIENT IS STABLE AND CONTINUING ON BACKUP PLAN. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED DUE TO AN ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147248 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening