MAUDE Adverse Event Report: ANIMAS LLC 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) 2018, the reporter contacted animas, alleging a power (damage with moisture ingress) issue.It was reported that the pump had intermittent power and has a crack and corrosion in the battery compartment.The patient's blood glucose (bg) reading was up to 311 mg/dl without specific symptoms of hyperglycemia.It was said that the patient gave a bolus to help lower bg to normal.This incident does not meet animas' definition of 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 24-jul-2018 with the following findings: a review of the black box showed one power on reset event was recorded after a replace battery alarm the battery compartment was cracked above and below the bumper pad.Corrosion was observed inside the battery compartment.The returned battery cap had stripped threads.The battery cap was unable to maintain an electrical connection.The reported power complaint was duplicated.The test battery cap was able to fit to maintain an electrical connection.The test battery cap was used to complete a 24 hour duration test.No power on reset events were duplicated during this time.A leak test failed with a battery compartment leak.The pump cover was removed to find no further evidence of moisture on the printed circuit board or internal components.No damage was found to the power circuit.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7703947
• Report Number: 2531779-2018-13200
• Device Sequence Number: 756962
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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