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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Moisture Damage (1405); 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) 2016, the reporter contacted animas, alleging a power (damage with moisture ingress) issue.It was reported that there is an intermittent power issue.It was also reported that there is damage and moisture ingress to the battery compartment.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
The device has been returned and evaluated by product analysis on 09/24/2016 with the following findings: black box shows unexpected power on reset event on (b)(6) 2016, the battery compartment and battery cap are undamaged , returned battery cap was fastened and then unscrewed ½ turn with no reboots occurring.No evidence of moisture corrosion is observed in the battery canister or behind the display.Leak test passed.¿ez-prime¿ steps were performed correctly, no power interruption occurred during the investigation.Unable to duplicate ¿power¿ complaint.The pump¿s cover was removed, no moisture corrosion or intermittent condition was found to the cgm module or to the printed circuit board.
Additional Manufacturer Narrative
Follow-up #2 date of submission 12/08/2016-correction to serial #.

• 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: 5874282
• Report Number: 2531779-2016-20851
• Device Sequence Number: 6271
• Product Code: LZG
• UDI-Device Identifier: 10840406100563
• UDI-Public: 0110840406100563
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/05/2016

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: 08/17/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/05/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/12/2016
• Supplement Report FDA Received Date: 10/19/2016; 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR