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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 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. It was reported that the pump emitted loss of prime warnings despite cartridge changes. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
 
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 11/29/2016 with the following findings: a review of the pump¿s black box showed that the data from (b)(6) 2016 had been overwritten due to continued use of the pump. No evidence of loss of prime was observed. There was one cs162 warning recorded after a rewind operation on (b)(6) 2016. During testing, the pump successfully completed the ez-prime steps were performed and no alarms or warnings occurring. The pump was exercised for 24 hours with no loss of prime or warnings occurring. The loss of prime issue was not duplicated during investigation. The pump's cover was removed and an intermittent condition was found to the force sensor flex due a broken solder joint around the pin. Unrelated to the complaint, investigation revealed a cracked battery compartment. The returned battery cap was undamaged and was able to fit securely to the pump. 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 Key6038950
MDR Text Key57803564
Report Number2531779-2016-29008
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 consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 09/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2016
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 Manufacturer11/17/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age6 MO
Event Location No Information
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2016
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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