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

Device Problem Battery Problem (2885)

Patient Problem Hyperglycemia (1905)

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 a power (battery life) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.It was reported that the user blood glucose (bg) reading was greater than 250 mg/dl; however, the bg reading did not exceed 500 mg/dl.No symptoms of hyperglycemia were reported.The alleged bg excursion does not meet animas criteria for a serious injury and is therefore not reportable as an adverse event.

Manufacturer Narrative

Follow-up # 1 date of submission 5/04/2016 device evaluation: the device has been returned and evaluated by product analysis on 4/18/2016 with the following findings: a review of the pump¿s black box data showed no evidence of a short battery life.One low battery warning associated with normal battery usage was observed in the pump¿s black box history.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.The test battery cap was able to fully tighten to the pump.The electrical current draws measured within specifications.A "battery life" issue was not duplicated during the investigation.During visual inspection of the pump, it was observed that the battery compartment had two cracks and the pump case was cracked in upper right hand corner of the display area.The pump case was removed and disassembled and there was no evidence of moisture or loose components inside the pump.It was also observed that the pump powered on to a dim and discolored display screen with the test battery cap.(b)(4).

• 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: 5547180
• MDR Text Key: 42084922
• Report Number: 2531779-2016-07179
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• 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: 03/22/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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