MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Dizziness (2194)

Event Date 04/06/2016

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.

Event Description

On (b)(6) 2016, the reporter contacted animas alleging the patient experienced an adverse event while on insulin pump therapy.The patient reportedly experienced a blood glucose (bg) value of 63 mg/dl with severe dizziness and lightheadedness.The patient reportedly was admitted in the hospital from (b)(6) 2016 due to congestive heart failure and had change in medication.The health care provider reportedly adjusted the pump's settings before and after the adverse event.It was also noted that the patient failed to bolus and had incorrect manual calculations of dosages.The patient reportedly also had a change in nutrition, physical activity and stress.This complaint is being reported because the patient had an adverse event due to use error and diabetes management issues with the device and due to unrelated health issues.Animas customer technical support reportedly referred the patient to the hcp for assistance with diabetes management issues.There was no indication of a pump malfunction and the patient remained on insulin pump therapy.

Manufacturer Narrative

Follow-up #1: date of submission 12/13/2016 device evaluation: the device has been returned and evaluated by product analysis on 11/16/2016 with the following findings: the pump's black box data from the date of the event had been overwritten due to continued use of the pump.The pump booted to the verify screen with audible and vibratory features.The pump completed a 24 hour duration test with no alarms.The pump¿s bolus calculation feature was found to be functioning properly.The available daily insulin delivery totals correctly reflected the user's programmed basal rates.The pump passed a delivery accuracy test and was found to be delivering within the required range.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• 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: 5782787
• MDR Text Key: 49186501
• Report Number: 2531779-2016-15464
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 53 MO
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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: 84 YR
• Patient Weight: 164