MAUDE Adverse Event Report: ANIMAS LLC 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 that the pump had no power and the battery compartment was damaged.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.There was no serious injury associated with this complaint.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 16-aug-2018 with the following findings: a review of the black box showed unexplained power on reset events had occurred.The battery compartment was cracked above and below the bumper pad.No moisture/corrosion was observed in the battery compartment.The returned battery cap had stripped threads and 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.The pump cover was removed to find no evidence of internal moisture or damage to the power circuit.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 LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7706578
• Report Number: 2531779-2018-13248
• Device Sequence Number: 13636376
• Product Code: OYC
• UDI-Device Identifier: 10840406100280
• UDI-Public: 10840406100280
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 07/03/2018

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: 08/13/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR