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

Medical Device Problem Code	Failure to Prime (1492)
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 prime (prime issue) issue.The reporter alleged the pump primed over 50 units incorrectly during the prime sequence.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in the over delivery of insulin.
Additional Manufacturer Narrative
Follow-up #1: date of submission (b)(4) 2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2018 with the following findings: a review of the black box verified the no cartridge detected alarm when the load step was activated.The loss of prime with a zero force was also recorded in the black box.Investigation duplicated a partial load malfunction.The sensor was unable to detect the force during the load step and continued to force out approximately 60 units.The pump was opened and moisture corrosion was located in the force sensor housing.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• 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: 7746512
• Report Number: 2531779-2018-14123
• Device Sequence Number: 1705831
• Product Code: OYC
• UDI-Device Identifier: 10840406100334
• UDI-Public: 10840406100334
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• 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): 07/14/2018

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: 08/14/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 25 MO
• Initial Date Received by Manufacturer: 07/14/2018
• Supplement Date Received by Manufacturer: 07/14/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR