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

Device Problem Pumping Problem (3016)

Patient Problems Hypoglycemia (1912); Ambulation Difficulties (2544)

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) 2019, the reporter contacted animas alleging that the patient experienced a blood glucose of 62 mg/dl with unsteadiness when standing and walking associated with an alleged history/settings issue.Reportedly, the patient remained on the pump and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support, the reporter stated they felt that the basal rates and bolus information were inaccurate on the pump starting on (b)(6) 2019 since the patient had a hypoglycemic event.Upon reviewing the basal information, basal rate at 8pm was supposed to be 0.375.But on (b)(6) 2019 at 8:03pm and 8:18pm the basal rate showed 0.000.There were no alarms around those times.There is a fill cannula record at 815pm of 0.000 but the reporter stated that the patient did not access the prime menu at those times and did not initiate any other activity that would have caused those 0.000s.This complaint is being reported because the patient experienced hypoglycemia associated with an alleged history/settings issue.

Manufacturer Narrative

Follow-up #1: date of submission 05-apr-2019 device evaluation: the device has been returned and evaluated by product analysis on 03-apr-2019 with the following findings: a review of the pump history showed the daily insulin delivery totals correctly reflected the programmed basal rates.The basal change history for 03/01/2019 showed 0 unit basal rates at 8:03pm and 8:15pm.The black box showed a cartridge change occurring at 8:03pm and a cannula bolus at 8:15pm on 3/1/19.The pump passed delivery accuracy testing and was found to be delivering within the required specifications.The basal change history was recording changes to the basal program accurately.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.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.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8419075
• MDR Text Key: 138758504
• Report Number: 2531779-2019-01845
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 9 YR
• Patient Weight: 18