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

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Structural Problem (2506)

Patient Problems Hyperglycemia (1905); Urinary Frequency (2275); Polydipsia (2604)

Event Type  Injury  

Manufacturer Narrative

The pump 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.

Event Description

On (b)(6) 2019, the reporter contacted animas alleging that the patient experienced a blood glucose of 14.6 mmol/l with polyuria, polydipsia, and extreme drowsiness associated with an alleged power 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 alleged that there was no power to the pump and there was rush, moisture and a crack in the battery compartment.This complaint is being reported because the patient experienced hyperglycemia associated with an alleged power with damage/moisture issue.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 04-sep-2019 with the following findings: during investigation the pump was returned with a stripped battery cap and a cracked battery compartment.Due to the stripped battery cap threads the cap was unable to secure and power on the ump.A test battery cap was able to secure and power up the pump.There was evidence of moisture corrosion located inside the battery compartment.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: 8881478
• MDR Text Key: 153950002
• Report Number: 2531779-2019-04343
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/08/2019
• 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): Life Threatening
• Patient Age: 54 YR