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 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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 04/14/2016.Device evaluation: the device has been returned and evaluated by product analysis on 04/04/2016 with the following findings: investigators were able to confirm the original complaint during the black box data and alarm history review; however, the short battery life issue was not duplicated during the actual investigation.Evidence of short battery life was illustrated with a drastic 54 count voltage drop leading to a ¿replace battery¿ alarm.Ez-prime steps were performed correctly.The pump electrical current draws were tested and were noted to be within specifications.Upon removal of the pump cover, no further moisture ingress or any intermittent condition was found to the power and continuous glucose monitoring (cgm) circuits.Unrelated to the original complaint, the returned battery cap threads were stripped.The battery cap was unable to fit securely to the pump; therefore, a test cap was used during investigation.In addition, the battery compartment was cracked.Corrosion was observed in the battery canister terminal.A leak test was performed and failed due to a battery compartment leak.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: 5489050
• MDR Text Key: 40138317
• Report Number: 2531779-2016-05493
• 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
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• 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: 03/29/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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: 5 YR