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

Device Problems Crack (1135); Moisture Damage (1405); Device Stops Intermittently (1599)

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.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 that the pump intermittently lost power.The reporter also stated that the battery compartment was cracked, moisture was present behind the display lens, and the yellow o-ring of the battery cap was visible while attached to the pump.There was no indication that the product caused or contributed to an adverse event, and the reported issue was not resolved with troubleshooting.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Follow-up #1 date of submission 09/02/2016-product analysis: the device was returned and evaluated by product analysis on 08/08/2016 with the following findings: the power complaint could not be duplicated or confirmed with investigation.Review of the pump¿s black box found no history of related issues.A battery compartment crack was observed.Moisture was observed within the battery compartment.Leak testing revealed a battery compartment leak.The pump successfully completed a prime sequence and 24-hour exercise test without issue or alarm.Moisture was observed on the pump¿s printed circuit board.

• 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: 5820454
• MDR Text Key: 51006364
• Report Number: 2531779-2016-17336
• 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: 07/01/2016

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: 011084040610006821345746216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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: 49 YR
• Patient Weight: 350