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

Device Problems Device Alarm System (1012); Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 08/08/2015

Event Type  Death  

Manufacturer Narrative

The pump has been returned and evaluated by product analysis on 09/04/2015 with the following findings: the last pump basal delivery occurred on (b)(6) 2015 prior to an occlusion alarm at 10:58 am.The pump black box history revealed an occlusion occurring on (b)(6) 2015 at 5:31 pm; the pump was reprimed and the basal delivery resumed at 5:37 pm.On (b)(6) 2015, the pump emitted an occlusion alarm at 10:58 am, the pump was not reprimed until 1:12 pm when the pump emitted a call service 064 alarm for an occlusion during prime.A review of the total daily dose history showed that the daily insulin delivery totals correctly reflected the user programmed basal rates.During testing, the pump ez-prime steps were performed successfully and the pump was exercised for 24 hours without issues.A flow accuracy test was performed and the pump was found to be delivering within specifications.The pump was opened and confirmed no damage or intermittent conditions to the motor flex or connectors.No delivery related defects were found during testing.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

Event Description

On (b)(6) 2015, the reporter contacted animas to inquire if he could return the pump since he did not know what to do with it and indicated that the patient had passed away.The reporter didn't initially want to troubleshoot but wanted to know if he could return it to have it looked at since there was a question about a call service alarm on the pump around the time of the death.The reporter was able to power on the pump and review the alarm history which revealed an occlusion alarm on (b)(6) 2015 at 5:31 pm, an occlusion alarm on (b)(6) 2015 at 10:58 am, and a call service 064 on (b)(6) 2015 at 1:12 pm.The reporter was unsure what the patient was doing during the alarms.The reporter expressed some concern that the patient did not appear to have been responding to alarms appropriately.During troubleshooting, the reporter attempted the rewind, load, and prime sequence but received a call service 064 alarm during the prime step.The infusion set tubing was replaced and the pump was rebooted.The reporter confirmed that after replacing the tubing, the pump was able to complete the rewind, load, and prime steps appropriately and the reporter indicated that the cause of the alarm appeared to be the tubing.The reporter indicated seeing an area of the tubing that appeared different that the reporter believed may have been a blockage.This report is made based on the indication that the response to the pump alarms may have contributed to the patient's death.

Manufacturer Narrative

Follow-up #1 date of submission 01/05/2016: additional information: the death certificate was received on 01/04/2016.The cause of death as listed on the death certificate was diabetic ketoacidosis.

Manufacturer Narrative

(b)(4).

• 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: 5075084
• MDR Text Key: 25700954
• Report Number: 2531779-2015-32845
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• 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: 08/26/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 32 MO
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2012
• 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): Death
• Patient Age: 24 YR
• Patient Weight: 100