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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problem Failure to Prime (1492)
Patient Problems Chest Pain (1776); Dyspnea (1816); Hyperglycemia (1905); Vomiting (2144)
Event Type  Injury  
Manufacturer Narrative
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 made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a prime (incomplete prime steps) issue. The reporter stated that the patient had a blood glucose (bg) 28mmol/l with shortness of breath, vomiting and chest pain. The patient was hospitalized and treated with insulin via injection and iv glucose. Customer support (cs) completed troubleshooting and loss of primes occurred more than three times. This report is being made due to bg excursion the patient experienced due to a prime issue.
 
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Brand NameANIMAS VIBE
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 Key5822324
MDR Text Key50436611
Report Number2531779-2016-17403
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 07/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
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 Age10 MO
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2015
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: 07/26/2016 Patient Sequence Number: 1
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