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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 Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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. (b)(6).
 
Event Description
On (b)(6) 2016 the reporter contacted animas alleging that the pump had an intermittent power issue. There is no indication that the product issue caused or contributed to an adverse event. This complaint is being reported because the issue remained unresolved at the time of trouble shooting.
 
Manufacturer Narrative
Follow-up #1: date of submission 04/12/2016. Device evaluation: the device has been returned and evaluated by product analysis on 03/18/2016 with the following findings: a review of the black box indicated an unexplained reboot had occurred on (b)(6) 2016. Visual inspection revealed that the battery compartment was cracked and the battery cap threads were stripped. The battery cap contacts were within required specifications. The returned battery cap was unable to secure properly to the pump, and reboots were duplicated. A test cap was used to complete investigation with no further power interruptions. Using the test cap, the pump successfully completed a rewind, load, and prime sequence and a 24 hour test with no issues occurring. The pump cover was removed and no internal defects were found. Unrelated to the complaint, investigation revealed that the display was discolored. 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 Key5485891
MDR Text Key40036408
Report Number2531779-2016-05404
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 Patient
Type of Report Initial,Followup
Report Date 02/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age33 MO
Event Location No Information
Date Manufacturer Received02/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2013
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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