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

Device Problem Pumping Problem (3016)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Follow-up #1: date of submission 04/12/2016 device evaluation: the device has been returned and evaluated by product analysis on 03/30/2016 with the following findings: a review of the total daily dose history showed that the daily insulin delivery totals correctly reflected the user programmed basal rates.No alarms or pump conditions indicating a malfunction were recorded in black box or alarm history.A delivery accuracy test was performed and the pump was found to be delivering within specifications.No delivery related defects were found during testing.

Event Description

On (b)(6) 2016, the reporter contacted animas alleging a blood glucose over 500 mg/dl.No additional information was provided related to the event.The reporter contacted animas to follow up on the event and indicated that the pump was working appropriately associated with the event and declined any troubleshooting of the event.This report is made based on the allegation that the patient experienced hyperglycemia and use error was unable to be ruled out as a possible cause or contributor to the event.

• 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: jon mulberg ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 10528350
• MDR Text Key: 206765411
• Report Number: 2531779-2020-00268
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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: 03/23/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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 Age: 75 YR