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

Device Problems Device Alarm System (1012); Failure to Prime (1492)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

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.(b)(6).

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging that there was a loss of prime issue with the pump.Reportedly, the pump failed to give audio alert and the user experienced high blood glucose (bg) excursion form the normal range of 108 㠱98 mg/dl.The value of bg excursion was not specified and the user did not report any associated symptoms.The reported bg excursion did not meet the criteria for a serious injury.This complaint is being reported because the reported prime issue was not resolved with troubleshooting.

Manufacturer Narrative

Follow-up #1: date of submission 03/24/2016 - device evaluation: the pump has been returned and evaluated by product analysis on (b)(4) 2016 with the following findings: 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.On investigation, the alleged absence of loss of prime alert issue was not verified in the black box or duplicated during the evaluation.Review of the black box data found that the available date range did not cover the complaint date due to continued customer use.Review of the available date range did not find any loss of prime alerts.The total daily delivery added up correctly and reflected the user¿s programmed basal rate.Using the returned caps, the pump powered up and functioned properly.A rewind/load/prime sequence and a 24-hour basal exercise were executed without any prime issues.Normal and audio bolus deliveries were executed and recorded correctly.Force sensor calibration readings were within specifications.All the boxes on the prime screen remained checked throughout the investigation.The pump gave the appropriate audible and visual no prime warning when the cartridge was removed during the investigation.Pump casing was opened and no anomalies were found with the force sensor assembly.

• 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: 5443928
• MDR Text Key: 38464678
• Report Number: 2531779-2016-04099
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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