BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2160889 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04905
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/14/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT HIS HIGH BLOOD GLUCOSE HAS NOT RESPONDED TO THE BOLUS INSULIN DOSES HE RECEIVED FROM THE ANIMAS INSULIN PUMP SINCE HE CHANGE HIS SITE ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT BEGAN TO CORRECT HIS BLOOD GLUCOSE WITH INSULIN VIA SYRINGE. HIS BLOOD GLUCOSE HAS BEEN RUNNING HIGH FOR (B)(6). THE PATIENT REPORTEDLY HAD SYMPTOM OF NAUSEA ON THE NIGHT OF (B)(6) 2011. AT THE TIME OF THE CALL TO ANIMAS ON (B)(6) 2011, HIS BLOOD GLUCOSE WAS AT "552 MG/DL." THE ANIMAS REPRESENTATIVE WALKED THE PATIENT THROUGH CHANGING THE SITE FOR DISPENSE OF INSULIN VIA ANIMAS PUMP. WITHIN TWO HOURS, HIS BLOOD GLUCOSE WAS LOWERED TO 432 MG/DL. WITH THE NEW SITE, THE PATIENT'S BLOOD GLUCOSE IS RESPONDING ACCORDINGLY VIA THE ANIMAS PUMP. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: THERE WAS NO BOLUS INSULIN DISTRIBUTION VIA THE ANIMAS PUMP FROM (B)(6) 2011 TO (B)(6) 2011 AS THE PATIENT WAS MANAGING HIS DIABETES VIA SYRINGE. THERE WERE NO LEAKAGE OR AIR BUBBLES FOUND IN THE INFUSION SET AND THE CARTRIDGE. THE PATIENT WAS ABLE TO PRIME SUCCESSFULLY DURING THE NEW SITE CHANGE ON (B)(6) 2011. THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD HIGH BLOOD GLUCOSE AFTER HE CHANGED THE SITE ON (B)(6) 2011. THE ISSUE WAS RESOLVED WITH TRAINING. HENCE, THIS COMPLAINT IS BEING REPORTED DUE TO A POSSIBLE USER ERROR.

    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 29 YR Life Threatening| R