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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 Problems Moisture Damage (1405); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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. 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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a temperature (temp-moisture ingress) issue. Reportedly the pump had a temperature issue after exposure to bath water and there was moisture/corrosion in the pump. The reporter denied any physical damage to the pump. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07/13/2016 with the following findings: a review of the black box indicated a sudden voltage drop had occurred leading to a ¿low battery¿ warning on (b)(6) 2016. Visual inspection revealed that the battery compartment was cracked and there was moisture/corrosion in the battery compartment and on the battery cap. Leak testing revealed a battery compartment leak. The pump powered on and successfully completed rewind, load, and prime steps. Sleep current draws were found to be above specifications, however no overheating was duplicated on investigation. The pump cover was removed and further moisture corrosion was observed on the printed circuit board and on the continuous glucose monitor module. Unrelated to the original complaint, investigation revealed that the display was 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 Key5659065
MDR Text Key45414088
Report Number2531779-2016-10058
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
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 05/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2016
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 Manufacturer05/31/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age28 MO
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2014
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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