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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 Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 02-aug-2019 with the following findings: a review of the pump black box or download history showed any activity related to temperature issues. No sudden drop in voltage readings was observed. A visual inspection of the pump revealed no evidence of damage to the battery compartment or returned battery cap. There was no evidence of moisture contamination inside the battery compartment. The returned battery cap was able to fit securely to maintain an electrical connection. The pump powered on and was exercised for 12 hours with no warnings, overheating, or power loss duplicated. The pump electrical current draws were within specification. The pump¿s cover was removed and no evidence of moisture or defects were observed to the power components. The complaint of a temperature issue was not duplicated during investigation. There was no defect found. 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.
 
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, the reporter contacted animas, alleging a temperature issue. No physical damage to the pump was reported. 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.
 
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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 Key6129621
MDR Text Key189429902
Report Number2531779-2016-32275
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2016
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? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Device Age17 MO
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2015
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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