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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); 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) 2018, the reporter contacted animas, alleging a power (damage) issue.The reporter alleged the battery compartment was cracked, and the top of the battery cap worn.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Follow-up # 1: date of submission 26-apr-2018.Device evaluation: the device has been returned and evaluated by product analysis on 18-apr-2018 with the following findings: a review of the pump black box data showed unexplained pump reboots.During visual inspection of the pump, it was observed that the battery compartment was cracked.The returned battery cap had stripped threads and was unable to fully attach to the pump; the pump reboots were duplicated with the returned battery cap.A new test battery cap was able to carefully attach to the pump and was used to complete a 24 hour duration test and it.There were no pump reboots duplicated during this time with the test battery cap.The pump cover was removed and there were no intermittent condition found to the power printed circuit board.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.

• 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: 7361126
• Report Number: 2531779-2018-05920
• Device Sequence Number: 173045
• Product Code: OYC
• UDI-Device Identifier: 10840406100235
• UDI-Public: 10840406100235
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: 03/27/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR