BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3053392 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04074
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 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 BLACK BOX HISTORY SHOWED LOSS OF PRIME WARNINGS ASSOCIATED WITH NON-ZERO LOW FORCE. A LOSS OF PRIME WAS RECORDED ON (B)(6) 2013 AT 22:27 AND DELIVERIES WERE NOT RESUMED UNTIL (B)(4) 2013 AT 10:54. A 1 UNIT PER HOUR BASAL PROGRAM WAS EXECUTED IN THE PUMP FOR A 24 HOUR DURATION AND NO LOSS OF PRIME WAS DUPLICATED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A FORCE SENSOR CALIBRATION CHECK FOUND THE PUMP TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO DEFECT WAS FOUND. 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.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PATIENT EXPERIENCED SEVERAL LOSS OF PRIMES. THE REPORTER STATED THAT THE PATIENT WAS ABLE TO DISCONNECT AND PRIME. THE PATIENT HAD USED DIFFERENT CARTRIDGES FROM DIFFERENT BOXES AND NO CHANGE WAS NOTED. THE REPORTER STATED THAT THE PATIENT CHANGES SITES EVERY THREE DAYS. THE PUMP LOST PRIME WHILE THE PATIENT WAS SLEEPING. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 590MG/DL WITH NAUSEA AND LARGE KETONES. THE PATIENT WAS TREATED WITH CORRECTION VIA SYRINGE. CUSTOMER SUPPORT REVIEWED BASAL HISTORY AND AN INTERRUPTION OCCURRED AT 10:16PM AND WAS NOT RESUMED UNTIL 10:54AM. WHEN THE PATIENT WOKE UP THEY RE-PRIMED WITH 0.5 UNITS AND AGAIN WITH 0.6 UNITS. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED DUE TO ALLEGATION OF A RECURRING LOSS OF PRIME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155681 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening