MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCH PING - INSULIN PUMP; GLUCOSE OXIDASE, GLUCOSE

Device Problem Obstruction of Flow (2423)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 10/15/2011

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on (b)(6) 2012, a customer's husband contacted roche diagnostics and reported an event that occurred on (b)(6) 2011.The customer's husband tried to awaken her, but she was not responsive so he called an ambulance.Husband tested her with the accu-chek compact plus meter and kept getting hi, which on the system indicates a result in excess of 600 mg/dl.The ambulance transported her to a hospital, where a lab test result was 995 mg/dl.She was admitted for a week.The customer was using a one touch ping insulin pump at the time.Her husband stated that the infusion was blocked and not giving her insulin and that is why she became hyperglycemic.The one touch ping insulin pump mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ONETOUCH PING - INSULIN PUMP
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): ANIMAS CORPORATION
• MDR Report Key: 17534822
• MDR Text Key: 321052321
• Report Number: MW5141721
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1