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

Device Problem Inaccurate Delivery (2339)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Type  Injury  

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

The reporter contacted animas on (b)(6) 2016 alleging the patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring 33 mmol/l with associated symptoms of large urinary ketones dehydration, polyuria, rapid pulse and deep breathing.The patient was hospitalized with the diagnosis of diabetic ketoacidosis and treated with intravenous glucose.The reporter alleged an inaccurate delivery issue with the pump; however, troubleshooting performed by animas customer technical support revealed basal delivery totals in the total daily dose record were as expected and the basal history matched the active basal program settings, the pump was recommending bolus totals correctly.No inaccurate delivery issues were indicated during troubleshooting; the pump is being returned to the manufacturer for investigation.This complaint is being reported because the reporter alleged the patient experienced a serious injury requiring hospitalization while on insulin pump therapy due to a pump malfunction; inaccurate delivery of insulin to the patient.

Manufacturer Narrative

Follow-up #1: date of submission 12/28/2016.Device evaluation: the device has been returned and evaluated by product analysis on 12/02/2016 with the following findings: a review of the black box indicated an unexpected loss of prime warning occurred at 14:17 on (b)(6) 2016.The warning was confirmed multiple times.A no cartridge detected warning occurred at 17:59 on (b)(6) 2016 and deliveries never resumed.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.The pump successfully completed a rewind, load, and prime sequence.The pump was exercised for 24 hours with no issues occurring.The pump passed delivery accuracy testing and was found to be delivering within required specifications.No delivery interruptions and no errors, alarms, or warnings occurred during investigation.The force sensor was found to be detecting the correct force.The pump cover was removed and no internal defects were found.The complaint could not be confirmed or duplicated on investigation.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.

• 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: 6084903
• MDR Text Key: 59333724
• Report Number: 2531779-2016-30811
• 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: 10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• 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: 11/22/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 10/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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