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

Device Problems Corroded (1131); Moisture Damage (1405); Device Stops Intermittently (1599)

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

Event Type  malfunction  

Manufacturer Narrative

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. 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 an intermittent power issue with the pump. There was reportedly moisture and corrosion in the battery compartment. There was no indication of damage 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 06/01/2016. Device evaluation: the device has been returned and evaluated by product analysis on 05/12/2016 with the following findings: multiple unexpected power on reset (por) events were observed on 04/04/2016. The battery compartment was found to be cracked from the finger pad down to the case seal. The returned battery cap secured to the pump and maintained electrical connection. During testing, the battery cap was fastened and then unscrewed ½ turn with no reboots. There was no evidence of moisture or corrosion observed in the battery compartment. A leak test revealed a battery compartment leak. The ¿ez-prime¿ steps were performed correctly; there were no power interruptions or any errors, alarms or warnings that occurred during the investigation. The pump¿s cover was removed; there was no moisture ingress or any intermittent conditions found to the power circuit or to the cgm module. The reported ¿power¿ complaint was unable to be duplicated during investigation. 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: 5591834
• MDR Text Key: 43849145
• Report Number: 2531779-2016-08181
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 23 MO
• Event Location: No Information
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown