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

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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) 2016, the distributer contacted animas alleging the "pump stopped." it was noted that animas customer technical support (ct) made multiple attempts to obtain additional information and was unsuccessful.The health care company reportedly insisted that the patient used the vibe pump for a long time and knows how to use it.The patient reportedly did not trust the device and received a replacement.This complaint is being reported because the pump was unable to be used by the patient due to a non-specific pump malfunction that was unresolved.There was no reported adverse event associated with this complaint.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 05/12/2016 with the following findings: a review of the pump user setting revealed the max daily delivery was set to 40 units.A review of the black box revealed multiple ¿call service (cs) 165¿ alarms exceeded the max daily delivery warnings on (b)(6) 2016 at 9:15pm as a result of 39.9 units (11.9u basal+28u bolus) reflected in the total daily dose (tdd) on (b)(6) 2016.A power interruption was recorded post the ¿cs165¿ warning from (b)(6) 2016 at 10:24pm until (b)(6) 2016 at 09:35am where basal delivery was resumed.The tdd added up correctly and reflected the programmed basal rate target.There was no damage found to the battery compartment or battery cap.The battery cap secured tightly to the pump and maintained electrical connection.During testing, the ¿ez-prime¿ steps were performed correctly; a 10 unit (u) test normal bolus was correctly delivered and recorded.The pump reflected 24u after a 24 hour (hr) 1u/hr duration test.There were no power interruptions or any errors, alarms or warnings that occurred during investigation.The product performed within specification and the reported ¿pump stopped¿ complaint was not duplicated during investigation.(b)(4).

• 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: 5608764
• MDR Text Key: 44176440
• Report Number: 2531779-2016-08548
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

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: 04/27/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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