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

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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) 2018, the reporter contacted animas, alleging a history/settings (history/settings issue) issue.The reporter alleged the pump was not calculating the basal rates accurately.Troubleshooting completed by animas customer support revealed the basal history did not match the active basal program.It was reported that the patient experienced a blood glucose level of above 250 mg/dl but below 500 mg/dl, without any other symptoms of hyperglycemia.This incident does not meet animas's definition of an adverse event.This complaint is being reported because there is an allegation against the delivery function of the pump.

Manufacturer Narrative

Date of submission 07-jun-2018 the device has been returned and evaluated by product analysis on 30-may-2018 with the following findings: a review of the pump history showed the total daily doses added up correctly and reflected the programmed basal rate target.The battery cap was not returned and all testing was performed with a test battery cap.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours with a 1 unit per hour basal rate and at the end of testing the pump correctly reflected the expected 24 units.The pump performed within specifications and the alleged inaccurate delivery issue was unable to be duplicated during the investigation.Unrelated to the original complaint, the battery compartment was cracked at the threads on the side.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 CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7443230
• MDR Text Key: 105922451
• Report Number: 2531779-2018-07700
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 24 MO
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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 Age: 53 YR