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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 Stops Intermittently (1599)
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 power (intermittent power) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1 date of submission 04/08/2016-product analysis: the device was returned and evaluated by product analysis on 03/28/2016 with the following findings: the complaint could not be duplicated or confirmed with investigation.Review of the pump¿s black box revealed no related issues.A battery compartment crack was observed.The returned battery cap was able to secure properly to the pump without power issue.The cap¿s contact dimensions were within specification and the cap was undamaged.The pump successfully completed a prime sequence and 24-hour exercise test without issue or alarm.No damage or defect was found to the pump¿s internal components.Unrelated to the complaint, investigation revealed the display screen was dim and discolored.
 
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Brand Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key5471551
MDR Text Key39645504
Report Number2531779-2016-05014
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 02/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age17 MO
Date Manufacturer Received02/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age21 YR
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