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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914)

Event Type  malfunction  

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)(6).

Event Description

On (b)(6) 2019, the reporter contacted animas and alleged the patient experienced on (b)(6) 2019 a blood glucose of 25mmol/l, symptoms of dehydration, and low blood pressure, associated with an unspecified issue.Reportedly, the patient discontinued pump therapy, and was treated in the hospital with intravenous fluids, and insulin via injection.The reporter was not able to provide further information during the initial complaint.Customer technical support made attempts to contact the reporter for additional information and troubleshooting, without success.This complaint is being reported because the patient allegedly experienced hyperglycemia and hospitalization 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 02-apr-2019 with the following findings: during investigation, the daily insulin delivery totals correctly reflect user's programmed basal rates.There was no activity outside normal use observed in the black box or download history.The pump passed delivery accuracy test and found to be delivering within required specifications.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• 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: 8372625
• MDR Text Key: 137692210
• Report Number: 2531779-2019-01537
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• 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
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention