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

Device Problem 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 a power (damage with moisture ingress) issue.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 09/23/2016.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.Device evaluation: the device has been returned and evaluated by product analysis on 08/30/2016 with the following findings: review of the black box data and pump history revealed multiple records of power on reset following manual time and date changes and/or pump not primed or replace battery alarms.The returned battery cap was able to secure properly to the pump.The pump was exercised for 24 hours without loss of power.Investigation did not duplicate a power issue.Damage and moisture was confirmed; the battery compartment was cracked and a piece of the case was missing.There was moisture inside the battery compartment.Leak testing confirmed moisture leakage due to the battery compartment crack.The pump was opened for further investigation and revealed moisture on the battery canister.Unrelated to the original complaint, the display was noted to be dim/faded and discolored.

• 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: 5845703
• MDR Text Key: 52439077
• Report Number: 2531779-2016-18795
• 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: 07/14/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 31 MO
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2013
• 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: 7 YR