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

Device Problem Appropriate Term/Code Not Available (3191)

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

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.

Event Description

On (b)(6) 2018, the reporter contacted animas and alleged the patient experienced on (b)(6) 2017 a blood glucose of 32mg/dl, with confusion, and unsteadiness when standing and walking, associated with and alleged inaccurate delivery issue.Reportedly, the patient resumed treatment with the same pump, and was given food and/or drink as treatment by a non-healthcare provider.The reporter was not able to provide further information during the initial complaint.This complaint is being reported because the patient allegedly experienced hypoglycemia while on the insulin pump, and the pump could not be ruled out as a contributing factor.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 27-nov-2018 with the following findings: review of the available pump data revealed the data from the date of the reported event, (b)(6)2018 was not available because it had been overwritten due to continued use of the device after the alleged event; the pump was in use for deliveries until (b)(6)2018.Review of the available data revealed the total daily doses add up to correctly reflect the user¿s basal program.The black box data nor the pump history showed any evidence of a delivery malfunction.The pump was exercised for 12 hours without any delivery issue and accuracy testing showed the pump was delivering accurate as programmed.Investigation did not confirm nor duplicate the complaint.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: kristen lopolito ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 8053929
• MDR Text Key: 126635648
• Report Number: 2531779-2018-19390
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• 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: 11/12/2018
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 200