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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 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 other (unusual issue) issue. On (b)(6) 2016, the reporter contacted animas, alleging an other (unusual issue) issue. It was reported that the basal program was activated around 1:00 pm that day and around 4:00 pm, an alarm was emitted stating the basal program was empty. The alarm would not clear after attempts to reboot the pump and change the battery. When pump was rebooted this message immediately came up; no verify screen appeared. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the reported issue was not resolved with troubleshooting.
 
Manufacturer Narrative
Follow-up #1 date of submission 02/02/2017-correction to serial #.
 
Manufacturer Narrative
Follow-up # 2 date of submission 3/10/2017 device evaluation: the device has been returned and evaluated by product analysis on 2/15/2017 with the following findings: during testing, the pump powered on properly with no alarms. The pump¿s ¿ez-prime¿ steps were performed correctly and the pump was exercised for 24 hours on 1 unit per hour basal program with no alarms occurring. The pump history showed that the active basal program was set to 0 and as a normal function; this would lead the pump to give an ¿active basal program empty¿ alarm which was observed in the pump¿s black box history. No defects were found on investigation therefore the investigation was unable to duplicate the initial complaint. 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. (b)(4). Follow-up #1 date of submission 3/10/2017 - correction to device available for evaluation: product was returned to the manufacturer on 2/7/2017.
 
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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 Key6230554
MDR Text Key64342413
Report Number2531779-2017-00516
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10840406100198
UDI-Public011084040610019821273649916
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,Followup
Report Date 12/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2017
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 Manufacturer02/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age0 MO
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2016
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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