MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP

Device Problem Use of Device Problem (1670)

Patient Problems Hyperglycemia (1905); 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.(b)(4).

Event Description

On (b)(6) 2019, the reporter contacted animas and alleged the patient experienced a blood glucose of 50mg/dl, with unsteadiness with standing and walking, and a blood glucose of 350mg/dl, with nausea, associated with an alleged inaccurate delivery 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, it was revealed the basal delivery totals in total daily dose did not match due to an accessed basal edit, and prime menu.Changes were also made to the pump basal program.The basal history matched the active basal program settings.The bolus totals matched, and all boluses were recorded as programmed.The patient alleged the pump was not delivering as it was supposed to.This complaint is being reported based on the allegation that the patient experienced hyperglycemia and hypoglycemia associated with use error of the pump.

• Brand Name: ANIMAS VIBE
• 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: 8258433
• MDR Text Key: 133462716
• Report Number: 2531779-2019-00505
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406100242
• UDI-Public: 10840406100242
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130007
• 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
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• 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
• Patient Age: 50 YR
• Patient Weight: 158