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 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 or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a power (battery life w/ damage) issue.It was noted that the battery compartment was cracked.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07/18/2017 with the following findings: a review of the black box showed the user installed partially discharged batteries resulting in replace battery alarms.The battery compartment was cracked on the side from the threads to the cover.Unrelated to the original complaint, moisture was found in the battery compartment.Additionally, the battery cap was not returned and a test cap was used for all testing.A leak test failed due to a battery compartment leak.The current draws measured within specifications.The pump cover was removed to find moisture on the printed circuit board and continuous glucose monitoring module.A battery life issue was not duplicated during testing.

• 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: 6659803
• Report Number: 2531779-2017-13130
• Device Sequence Number: 1882090
• Product Code: OYC
• UDI-Device Identifier: 10840406100570
• UDI-Public: 0110840406100570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/27/2017

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: 07/05/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 05/27/2017
• Supplement Date Received by Manufacturer: 05/27/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR