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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 Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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, animas received notification from the health care company indicating an issue with the pump. There was no indication that the product caused or contributed to an adverse event. There was no additional information available for this complaint. This complaint is being reported due to non-specific device issue.
 
Manufacturer Narrative
The pump has not been returned to animas for evaluation. 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. 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. A 3500a supplemental report was submitted to revise incident description.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging an other (unusual issue) issue; the reporter requested certificate of destruction for the pump as the pump is out of warranty. There was insufficient information to categorize the reported issue as a reportable product malfunction. There was no indication that the pump caused or contributed to an adverse physical event. Animas customer technical support requested more information from the reporter regarding the pump; however, no further information was available. If additional information becomes available, the information will be evaluated and reported if applicable.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 12/21/2016 with the following findings: during a visual inspection of the pump, the battery compartment was observed to be cracked in two places. Additionally, the pump was powered on and the display screen appeared dim and discolored.
 
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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 Key6082755
MDR Text Key59566301
Report Number2531779-2016-30726
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
Type of Report Initial,Followup,Followup
Report Date 10/13/2016
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 Manufacturer11/19/2016
Was the Report Sent to FDA? Yes
Device Age35 MO
Event Location No Information
Date Manufacturer Received10/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2013
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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