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

Device Problems Premature Discharge of Battery (1057); Crack (1135); Battery Problem (2885); Moisture or Humidity Problem (2986)

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 that battery life of the pump was less than expected.The reporter claimed that the battery compartment was cracked and there was moisture in the battery compartment.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.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 10/04/2016.Device evaluation: the device has been returned and evaluated by product analysis on 09/09/2016 with the following findings: a review of the pump¿s black box revealed evidence of a short battery life in a form of a sudden voltage drop leading to a cs 128 alarm.The battery compartment was found to be cracked at the threads on the side.The returned battery cap was able to fit securely.There was moisture corrosion observed in the battery canister.A leak test failed due to battery compartment leak.The pump powered up correctly and the ez-prime steps were performed correctly.All currents draw were within specification.The ¿short battery life¿ complaint was unable to be duplicated.The pump¿s cover was removed and there was no moisture ingress or any intermittent condition found to the 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: 5845759
• MDR Text Key: 52491141
• Report Number: 2531779-2016-18846
• 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: 07/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610010521809847216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 07/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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
• Patient Age: 51 YR