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

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Lethargy (2560)

Event Type  Injury  

Manufacturer Narrative

The pump has not been returned to animas.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.(b)(4).

Event Description

On (b)(6) 2016, the reporter contacted animas alleging the patient experienced a blood glucose (bg) measurement greater than or equal to 250mg/dl (13.8mmol/l) with large ketones.There was no indication of the exact the bg value.The patient reportedly was in diabetic ketoacidosis (dka) and experienced symptoms of extreme drowsiness, nausea and vomiting.The patient reportedly was treated via intravenous insulin injections and intravenous fluids by the emergency medical services.Animas customer technical support reportedly reviewed the pump with the patient: the basal delivery totals in the total daily dose reportedly matched the active basal program.The basal history reportedly matched the active basal program settings.The patient reportedly was able to deliver a 1 unit air bolus via the pump.The bolus totals reportedly matched and accurately recorded as programmed in the pump history.It was noted that the patient discontinued insulin pump therapy.Animas customer technical support reportedly referred the patient to the health care provider for assistance with diabetes management issues.There was no indication of a delivery issue with the pump after troubleshooting; however, this complaint is being reported as the patient experienced hyperglycemia while using insulin pump therapy.

Manufacturer Narrative

Follow-up #1: date of submission 11/03/2016.Device evaluation: the device has been returned and evaluated by product analysis on 10/10/2016 with the following findings: a review of the black box revealed an unexplained loss of prime on (b)(6) 2016 at 17:44; followed by a power on reset (por) event at 17:47.A review of the pump history revealed the pump was powered back on and deliveries resumed on (b)(6) 2016 at 12:22.On (b)(6) 2016 at 02:07 an unexplained por event occurred.The pump was powered back on and deliveries resumed at (b)(6) 2016 at 18:05.The last basal delivery was on (b)(6) 2016.The total daily dose added up correctly and reflected the users programmed basal rates.During testing, the pump passed the delivery accuracy test and was found to be delivering accurately and within range.No delivery interruptions or any errors, alarms or warnings occurred during investigation.The reported complaint was not duplicated during investigation.Unrelated to the complaint, the battery compartment was observed to be cracked above and below the bumper pad.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: 5915738
• MDR Text Key: 53548435
• Report Number: 2531779-2016-23505
• 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: 08/25/2016

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: 09/16/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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; Required Intervention
• Patient Age: 28 YR