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

Device Problems Break (1069); 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 reporter contacted animas, alleging a power (damage) issue.It was reported that the pump had lost power.Reportedly, the battery compartment had stripped threads and the battery cap was unable to tighten on to the pump.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1 date of submission 04/27/2016 device evaluation: the pump has been returned and evaluated by product analysis on 04/18/2016 with the following findings: a review of the black box data showed unexplained reboots.A visual inspection of the pump showed that the battery compartment was cracked.The returned battery cap has stripped threads and was unable to fully attach to the pump; reboots were duplicated with the returned battery cap.A test cap was used; the pump was then exercised for 24 hours with no issues.The pump cover was removed and not internal defect was found.

• 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: 5505070
• MDR Text Key: 40667475
• Report Number: 2531779-2016-06031
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

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
• Other Device ID Number: 011084040610005121166166716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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
• Patient Age: 45 YR
• Patient Weight: 152