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 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 (damage) issue.It was alleged that the battery compartment was cracked with intermittent power.There was no indication that the product caused or contributed to an adverse event.This issue 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 11/20/2017 with the following findings: review of the black box data revealed records of unexplained power on reset.On examination, the battery compartment was confirmed to be cracked as per the allegation.The returned battery cap was noted to have stripped threads and was not able to secure properly to the pump to maintain electrical connection; the alleged intermittent power issue was duplicated with the damaged battery cap on the pump.A test cap was placed on the pump for testing and was able to fit securely and maintain electrical connection for investigation.With the test cap in place, the pump powered on and was exercised for 24 hours without any interruption in power.There was no evidence of damage, defect or contamination of the pump¿s interior components.(b)(4).

• 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: 6953821
• Report Number: 2531779-2017-23929
• Device Sequence Number: 19110347
• Product Code: OYC
• UDI-Device Identifier: 10840406100099
• UDI-Public: 0110840406100099
• Combination Product (Y/N): N
• 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): 09/23/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/23/2017
• Supplement Date Received by Manufacturer: 09/23/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 165