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

Device Problem Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

The pump has been returned to animas but 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 an inaccurate delivery with the pump.The patient reportedly was hospitalized.It was noted the patient experienced ketones for the past 4 days.The patient reportedly was treated by the health care provider.There was no additional information received for this complaint.This complaint is being reported as the patient experienced hyperglycemia allegedly due to an inaccurate delivery issue with the pump.

Manufacturer Narrative

Follow-up #1: date of submission 10/11/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/30/2016 with the following findings: a review of the black box revealed the pump was manually suspended on (b)(6) 2016 at 20:15 and manually resumed at 21:04.The last basal delivery and the last bolus delivery were on (b)(6) 2016.The total daily dose added up correctly and reflected the users programmed basal rates.The pump was found to be delivering within required range and delivering accurately.There were no delivery interruptions or any errors, alarms or warnings that occurred during testing.The pump passed the delivery accuracy test with no delivery defects found.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.(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: 5928655
• MDR Text Key: 53934010
• Report Number: 2531779-2016-24136
• 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: 08/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Manufacturer Received: 08/07/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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 Outcome(s): Hospitalization; Life Threatening
• Patient Age: 3 YR