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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 Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue. It was reported that the pump repeatedly emitted loss of prime warnings despite cartridge changes. There was no indication that the product caused or contributed to an adverse event. This issue is being reported because it may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 12/29/2016 with the following findings: a review of the black box showed multiple loss of prime warnings with low non zero force. The rewind, load, and prime steps were performed successfully. The force calibration testing passed. The pump was exercised for 24 hours and no loss of prime alarms were duplicated. Unrelated to the original complaint, the battery compartment was cracked form the case seal to the grip pad. 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.
 
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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 Key6082980
MDR Text Key59574678
Report Number2531779-2016-30737
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10840406100037
UDI-Public011084040610003721259430116
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 10/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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