BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2122337 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04099
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. THE OWNER'S BOOKLET INSTRUCTS THE USER TO KEEP AN EMERGENCY KIT WITH THEM AT ALL TIMES AND STATES THAT TO AVOID THE RISK OF VERY HIGH BG, THE USER MUST BE PREPARED TO GIVE HIM/HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BLACK BOX REVIEW CONFIRMED THE PATIENT RECEIVED MULTIPLE REPLACE BATTERY ALARMS THAT WERE CONFIRMED. THE BLACK BOX VOLTAGE READINGS INDICATED THE PATIENT REPLACED THE BATTERY WITH ONE THAT WAS NOT FULLY CHARGED. ALL CURRENT DRAWS WERE MEASURED WITHIN SPECIFICATIONS EXERCISED PUMP FOR 24HRS WITH NO POWER ISSUES OR OCCLUSIONS DUPLICATED. NO EVIDENCE OF SHORT BATTERY LIFE OBSERVED IN THE BLACK BOX OR DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT SHE RECEIVED MULTIPLE REPLACE BATTERY ALARMS THE DAY BEFORE CONTACTING ANIMAS ON (B)(6). SHE ALSO SAID SHE RECEIVED A CS 064 ALARM DURING THE NIGHT ON (B)(6). THE PATIENT REPORTEDLY WOKE UP ON THE MORNING OF (B)(6) WITH A BLOOD GLUCOSE LEVEL OF "HI" ON THE METER WITH POSITIVE KETONES. THE PATIENT WAS GIVEN A CORRECTION BOLUS DOSE FROM THE PUMP BUT HER BLOOD GLUCOSE LEVEL HAS NOT YET BEEN RETESTED. THE PATIENT'S MOTHER SAID SHE WOULD CONTACT A DOCTOR FOR ASSISTANCE WITH THE PATIENT'S BACKUP INSULIN DELIVERY PLAN. THE PATIENT SAID SHE TRIED SEVEN DIFFERENT BATTERIES FROM THREE DIFFERENT PACKS OF BATTERIES. THE PATIENT ALSO SAID THAT SHE CONFIRMED ALL ALARMS WHEN RECEIVED AND CHANGED THE BATTERIES AFTER REPLACE BATTERY ALARMS. THE CUSTOMER SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO CHANGE THE SITE AND TUBING AS WELL SINCE THE USER HAD BEEN RECEIVING MULTIPLE CS 064 ALARMS AND OCCLUSION ALARMS.

    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 19 YR Life Threatening