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

Model Number 13920000

Device Problem Pumping Problem (3016)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The pump has not been returned to animas for evaluation.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) 2020, the reporter contacted animas and alleged that the ¿pump he (patient) lost but the pump malfunctioned and caused him to be hospitalized¿.Customer technical support (cts) was unable to determine what the issues were with the pump.Troubleshooting could not be completed at the time of the complaint.Cts made attempts to contact the reporter for additional information and troubleshooting, without success.This complaint is being reported based on the allegation that the patient was hospitalized due to issues with the pump.The pump could not be ruled out as a contributing factor.

• 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: jon mulberg ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 9903272
• MDR Text Key: 186412231
• Report Number: 2531779-2020-00102
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 13920000
• Device Catalogue Number: 13920000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 33 MO
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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): Hospitalization; Life Threatening
• Patient Age: 26 YR