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

Device Problem Device Issue (2379)

Patient Problems Hypoglycemia (1912); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

The device 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) 2018, the reporter contacted animas and alleged the patient experienced on (b)(6) 2018 a blood glucose of 2.6mmol/l, with unsteadiness when standing and walking, severe dizziness, confusion, and cognitive impairment, associated with an alleged inaccurate delivery issue.Reportedly, the patient remained on the pump and self-treated with food and/or drink.During troubleshooting with customer technical support, it was revealed the patient¿s healthcare provider adjusted the basal rate after the blood glucose excursion.It was alleged the basal history did not match the active basal.This complaint is being reported based on the allegation that the patient experienced hypoglycemia associated with an inaccurate delivery issue.

Manufacturer Narrative

Follow-up #1: date of submission (b)(4) 2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2018 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 device.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 range.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.The alleged issue could not be duplicated.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7601981
• MDR Text Key: 111076511
• Report Number: 2531779-2018-10934
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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-64
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 57 YR