BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2042034 · Received March 24, 2011

    Report

    Report Number
    2531779-2011-01948
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE DATA FROM THE ORIGINAL COMPLAINT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE CURRENT TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS AND REPORTED A LOW BLOOD GLUCOSE (BG) EVENT. THE PATIENT REPORTED A BG RESULT OF "51 MG/DL" OBTAINED. SHE INDICATED THAT THE EVENT OCCURRED ON (B)(6) 2011, AT AN UNSPECIFIED TIME. THE PATIENT HAD REPORTEDLY EATEN LUNCH AROUND 1:00 PM AND BOLUSED. THE PATIENT THEN WENT SHOPPING AROUND 3:30-4:00 PM. DURING THE TIME, THE PATIENT CLAIMED THAT HER VISION BECAME AFFECTED. SHE DESCRIBED HER VISION LIKE LOOKING AT A STROBE LIGHT. THE PATIENT FURTHER MENTIONED THAT AT ONE MOMENT, SHE WOULD SEE A PERSON AND THEN THEY WERE GONE. HOWEVER, LOOKING DOWN, THE PATIENT CLAIMED HER VISION WAS OK. THE PATIENT'S HUSBAND REPORTEDLY GAVE HER A SODA. AN HOUR LATER, HER BG ROSE TO "84 MG/DL." NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT DENIED THAT THE PUMP WAS EXPOSED TO AN MRI/CT/X-RAY. THE PATIENT ALSO DENIED RECEIVING EXTRA BOLUSES. THE PUMP'S SETTINGS WERE REVIEWED. THE PUMP'S TIME WAS CORRECT. THE BASALS WERE CORRECT IN THE ACTIVE PROGRAM. THE TDD FOR (B)(6) 2011 AND BOLUS/BASAL HISTORIES ADDED UP CORRECTLY. NO ASSOCIATED ALARMS WERE REPORTED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT ALLEGED THAT SHE DEVELOPED A SYMPTOM SUGGESTIVE OF LOW BLOOD GLUCOSE AND RECEIVED TREATMENT FROM HER HUSBAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R