MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Codes	Premature Discharge of Battery (1057); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a power (battery life with damage) issue.It was alleged that the top of the battery cap was worn.The reporter was not able to provide further information during the initial complaint.There was no indication that the product caused or contributed to an adverse event.The issue is being reported because it may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
Additional Manufacturer Narrative
Follow-up #1: the device has been returned and evaluated by product analysis on 10/09/2017 with the following findings: a review of the black box showed no evidence of a battery life issue.The battery compartment was cracked above and below the bumper pad.Corrosion was found in the battery compartment.The battery cap top was worn and threads were intact.The returned battery cap measurements were within specifications.The returned battery cap was able to attach to the pump and power it on.The pump electrical current draws were within specifications.A leak was found in the battery compartment.The pump cover was removed to find no moisture internally.The battery life issue was not duplicated during investigation.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6803448
• Report Number: 2531779-2017-18638
• Device Sequence Number: 13477946
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 0110840406100020
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR