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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 Battery Problem (2885)
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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life) 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 04/14/2016. Device evaluation: the device has been returned and evaluated by product analysis on 04/04/2016 with the following findings: investigators were able to confirm the original complaint during the black box data and alarm history review; however, the short battery life issue was not duplicated during the actual investigation. Evidence of short battery life was illustrated with a drastic 54 count voltage drop leading to a ¿replace battery¿ alarm. Ez-prime steps were performed correctly. The pump electrical current draws were tested and were noted to be within specifications. Upon removal of the pump cover, no further moisture ingress or any intermittent condition was found to the power and continuous glucose monitoring (cgm) circuits. Unrelated to the original complaint, the returned battery cap threads were stripped. The battery cap was unable to fit securely to the pump; therefore, a test cap was used during investigation. In addition, the battery compartment was cracked. Corrosion was observed in the battery canister terminal. A leak test was performed and failed due to a battery compartment leak. 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 Key5489050
MDR Text Key40138317
Report Number2531779-2016-05493
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
Type of Report Initial,Followup
Report Date 02/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2016
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 Manufacturer03/29/2016
Was the Report Sent to FDA? Yes
Device Age9 MO
Event Location No Information
Date Manufacturer Received02/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2015
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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