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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP

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ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP Back to Search Results
Device Problem Device Stops Intermittently (1599)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Urinary Frequency (2275); Polydipsia (2604)
Event Date 06/01/2016
Event Type  Injury  
Manufacturer Narrative
The pump has not been returned to animas. 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.
 
Event Description
On 06/03/2016 the reporter contacted animas alleging that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose (bg) of 399mg/dl with nausea, extreme drowsiness, extreme thirst, and excess urination associated with an intermittent power issue. The patient reportedly discontinued insulin pump therapy and was treated with insulin via injection, intravenous glucose, and other unspecified treatment. There was reportedly no moisture/corrosion in the battery compartment and the battery cap¿s yellow o-ring was not visible at the time of the alleged power issue. The reporter noted that the battery compartment was damage. This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an intermittent power issue.
 
Manufacturer Narrative
Follow-up #1 date of submission 06/30/2016: correction to incident description. 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.
 
Event Description
On (b)(6) 2016 the reporter contacted animas alleging that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose (bg) of 399mg/dl with nausea, extreme drowsiness, extreme thirst, and excess urination associated with an intermittent power issue. The patient reportedly discontinued insulin pump therapy and was treated with insulin via injection and other unspecified treatment. There was reportedly no moisture/corrosion in the battery compartment and the battery cap's yellow o-ring was not visible at the time of the alleged power issue. The reporter noted that the battery compartment was damaged. This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an intermittent power issue.
 
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Brand NameONETOUCHPING GLUCOSEMGMTSYSTEM
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key5735587
MDR Text Key47733028
Report Number2531779-2016-12389
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age23 MO
Event Location No Information
Date Manufacturer Received06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/20/2016 Patient Sequence Number: 1
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