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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
Date of submission 12/06/2017 the device has been returned and evaluated by product analysis on 11/11/2017 with the following findings: there were multiple loss of prime warnings observed in the black box with low non zero force. The pump was exercised for 24 hrs with no loss of prime duplicated. The force calibration was within specifications. Unrelated to the original complaint, the battery compartment was cracked. 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.
 
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. (b)(6).
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
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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 Key6037990
MDR Text Key107832529
Report Number2531779-2016-28968
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 09/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2016
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 Manufacturer11/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Device Age15 MO
Event Location No Information
Date Manufacturer Received09/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2015
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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