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 been returned to animas for evaluation.An investigation 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), the reporter contacted animas, alleging a power (damage) issue.It was reported that the battery cap could not tighten onto 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
Device evaluation: the device has been returned and evaluated by product analysis on 10-nov-2017 with the following findings: the black box history showed multiple unexplained power on reset events on (b)(6) 2017.The battery compartment was cracked from the threads down to the case seal on the side.The returned battery cap was undamaged and able to fit to the battery compartment.Evidence of moisture ingress was observed in the battery compartment.The leak test failed due the battery compartment leak.The battery cap was fastened and then unscrewed ½ turn leading to a reboot.The reported ¿power¿ complaint was duplicated due moisture corrosion.The battery cap was fastened again and the pump was exercised for 24 hours with no further reboots occurring.The pump¿s cover was removed; no further moisture ingress or any intermittent condition was found to the power pcb.(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: 6885468
• Report Number: 2531779-2017-21791
• Device Sequence Number: 108787
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 0110840406100020
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/31/2017

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: 09/14/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 113