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

Device Problem Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.(b)(6).

Event Description

On (b)(6) 2019, the reporter contacted animas, alleging a prime (loss of prime) issue.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.

Manufacturer Narrative

Device evaluation: the pump has been returned and evaluated by product analysis on 16-dec-2019 with the following findings: a review of the pump¿s black box showed evidence of a loss of prime warning due to the user not priming the pump after occlusion alarms on (b)(6) 2019.Occlusion was due to an unidentified high force.During testing, the pump successfully completed the rewind, load cartridge, and prime steps with no loss of prime warnings occurring.The pump was exercised for 12 hours with no loss of prime occurring.The force sensor calibration was found to be within required specification.Unrelated to the complaint, investigation revealed a cracked battery compartment and a dim/pink display screen.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.The loss of prime issue was shown in the pump history but was not duplicated during investigation.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: kristen lopolito ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 9236224
• MDR Text Key: 170235574
• Report Number: 2531779-2019-05861
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1