BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2970497 · Received February 20, 2013

    Report

    Report Number
    2531779-2013-01968
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY WAS REVIEWED AND SHOWED EVIDENCE OF THE TIME AND DATE REVERTING TO DEFAULT SETTINGS AFTER 1 HOUR OF BEING POWERED OFF ON (B)(4) 2013. THE PUMP WAS POWERED "ON" AND DISPLAYED THE "VERIFY" SCREEN AS EXPECTED. THE PUMP WAS POWERED "OFF" FOR 17 HOURS AND THEN IT WAS POWERED "ON"; THE PUMP WAS UNABLE TO MAINTAIN THE TIME AND DATE SETTINGS AFTER LESS THAN 24 HOURS OF BEING POWERED OFF. THE COVER WAS REMOVED AND THE PUMP WAS DISASSEMBLED; THE BT1 COMPONENT WAS FOUND TO BE LEAKING. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP WAS EXERCISED FOR 24 HOURS SUCCESSFULLY WITH NO ALARMS DUPLICATED DURING TESTING. THE PUMP PASSED THE (B)(4) FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING LOW BLOOD GLUCOSE (BG) OF 30 MG/DL WITH ASSOCIATED SYMPTOMS OF SWEATING AND SHAKINESS IN THE MIDDLE OF THE NIGHT ON AN UNKNOWN DATE. THE PATIENT REPORTED THAT SHE WAS ABLE TO SELF TREAT THE LOW BG BY CONSUMING FOOD AND DRINKING FLUIDS, WHICH REPORTED BROUGHT THE BG TO WITHIN NORMAL RANGE FOR THE PATIENT. THE PATIENT REPORTED THAT LATER THAT DAY HER BG ELEVATED TO 400 MG/DL AND DENIED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THIS REPORTED BG ELEVATION DOES NOT MEET ANIMAS'S CRITERIA OF A REPORTABLE ADVERSE EVENT. THE PATIENT REPORTED THAT FOR THE LAST TWO BATTERY CHANGES, THE TIME AND DATE OF THE PUMP REVERTED TO THE FACTORY DEFAULT SETTING. THE PATIENT REPORTED THAT SHE HAD NOT REALIZED THAT SHE HAD SET THE TIME AND DATE INCORRECTLY, MIXING UP THE AM/PM SETTING ON THE PUMP. AS A RESULT, THE PATIENT WAS RECEIVING NIGHTTIME BASAL BOLUSES DURING THE DAY AND DAYTIME BASAL BOLUSES DURING THE NIGHT, ACCOUNTING FOR THE REPORTED BG EXCURSIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG AS A RESULT OF INCORRECTLY SETTING THE TIME/DATE ON THE PUMP AFTER THE PUMP RESET TO THE FACTORY DEFAULT TIME/DATE WITH A BATTERY CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74470 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening