MAUDE Adverse Event Report: ANIMAS CORPORATION 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) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue.It was reported that the pump emitted loss of prime warnings despite cartridge changes.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 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 11/29/2016 with the following findings: a review of the pump¿s black box showed that the data from (b)(6) 2016 had been overwritten due to continued use of the pump.No evidence of loss of prime was observed.There was one cs162 warning recorded after a rewind operation on (b)(6) 2016.During testing, the pump successfully completed the ez-prime steps were performed and no alarms or warnings occurring.The pump was exercised for 24 hours with no loss of prime or warnings occurring.The loss of prime issue was not duplicated during investigation.The pump's cover was removed and an intermittent condition was found to the force sensor flex due a broken solder joint around the pin.Unrelated to the complaint, investigation revealed a cracked battery compartment.The returned battery cap was undamaged and was able to fit securely to the pump.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
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 6038950
• MDR Text Key: 57803564
• Report Number: 2531779-2016-29008
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

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
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1