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

Device Problems Crack (1135); 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 that the pump lost power, and the battery compartment was cracked.There was no indication that the product caused or contributed to an adverse event, and the reported issue was not resolved with troubleshooting.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Device evaluation: the pump was returned and evaluated by product analysis on 07/08/2016 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.A review of the pump black box data revealed multiple unexplained pump reboots, as well as cs 012, cs 052, and cs 054 call service alarms.During testing, the pump did not maintain power with the returned battery cap; the complaint was duplicated.The battery compartment threads were damaged, making it impossible to attach the cap to the pump to maintain power.The battery compartment was also observed to be cracked in two places.Unrelated to the complaint, the keypad cover was observed to be peeling and the pump casing was cracked near the display lens.(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: 5735105
• MDR Text Key: 47707175
• Report Number: 2531779-2016-12334
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• 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: 06/30/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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: 33 YR