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

Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that the pump was alarming.This complaint is being reported because the alleged issue could cause a delay in insulin 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 19-dec-2019 with the following findings: during investigation, the pump is unable to power on due to impact damage to display and pcb components.Unable to investigate pump is alarming complaint due to impact damage.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.
Event or Problem Description
Hold by yd, 1/7/2020.

• 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: 7570516
• Report Number: 2531779-2018-10246
• Device Sequence Number: 1262209
• Product Code: OYC
• UDI-Device Identifier: 10840406100341
• UDI-Public: 10840406100341
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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): 05/30/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR