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

Device Problem Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas.Evaluation has not yet been completed.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.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life) issue.His is potentially reportable as the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.There was no indication that the device caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 07/08/2016 device evaluation: the device has been returned and evaluated by product analysis on 06/24/2016 with the following findings: black box shows multiple eaw 128-fb80 alarms on multiple days.No battery cap or cartridge cap returned.All testing performed with test caps.Battery cap is able to fully tighten.Battery compartment intact.Pump case cracked adjacent to lower lh corner of keypad.During investigation a eaw 128-fe80 was received on each "rewind" attempt."idle and sleep" current draws within specifications.Removed pump case.Evidence of moisture damage inside pump on motor circuit and power circuit.Checklist fail due to internal moisture damage.

• 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: 5716321
• MDR Text Key: 47298474
• Report Number: 2531779-2016-11521
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610001321968985616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Date Manufacturer Received: 05/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• 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
• Patient Age: 55 YR
• Patient Weight: 142