BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1973039 · Received January 21, 2011

    Report

    Report Number
    2531779-2011-00398
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Report Date
    December 22, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS AND INDICATED THAT SHE WAS HOSPITALIZED FOR DKA. THE PT INDICATED THAT ON (B)(6) 2010, HER BLOOD GLUCOSE (BG) LEVEL WAS RUNNING AROUND "140 TO 180 MG/DL." THAT SAME DAY IN THE EVENING, THE PT REPORTEDLY ATE PART OF A BURRITO AND DID NOT CHECK HER BG DURING HOURS OF SLEEP. THE NEXT MORNING, THE PT WOKE UP VOMITING AND WITH A BG LEVEL OF "182 MG/DL." AT THAT POINT, THE PT'S PARENTS TOOK HER TO A HOSPITAL WHERE SHE WAS PLACED ON THE INSULIN DRIP. THE PT WAS OFF OF THE PUMP ON (B)(6) 2010 AND RECONNECTED ON (B)(6) 2010. DURING TROUBLESHOOTING, A REVIEW OF THE BOLUS HISTORY REVEALED THAT THE PT HAD NOT TAKEN ANY BOLUSES ON (B)(6) 2010. THE PT ADMITTED THAT SHE ALWAYS FORGETS TO BOLUS. A REVIEW OF THE TDD HISTORY INDICATED 25 UNITS FOR (B)(6) 2010. HOWEVER, THE BOLUS HISTORY SHOWED A 5 UNIT AIR BOLUS THAT THE ANIMAS REPRESENTATIVE WALKED THE PT THROUGH FOR THAT DAY. THE NEXT RECORD WAS A 10 UNIT BOLUS FOR (B)(6) 2010. THE PT DENIED THAT THE BATTERY HAD BEEN OUT OF THE PUMP. SHE DENIED CHANGING THE DATE OR TIME OF THE DEVICE. NO ALARMS WERE OBSERVED IN THE PUMP HISTORY. THE PUMP BASAL RATES WERE REPORTEDLY CORRECT. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE TDD HISTORY DID NOT CORRELATE WITH THE BOLUS HISTORY FOR THE DATE OF (B)(6) 2010. THERE IS NO EVIDENCE, HOWEVER, THAT THE DEVICE OR REPORTED ISSUE CONTRIBUTED TO THE PT'S INJURY. THE PT REPORTEDLY DID NOT TAKE ANY BOLUSES FOR 3 DAYS PRIOR TO THE HOSPITALIZATION FOR DKA.

    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