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

Medical Device Problem Codes	Premature Discharge of Battery (1057); Moisture Damage (1405)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to animas for evaluation.An evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (battery life w/ moisture) issue.The reporter alleged there was moisture in the battery compartment.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in long term cessation of insulin delivery if the user is unable to resolve the alarm.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 18-may-2018 with the following findings: a review of the pump¿s black box and alarm history showed a sudden drop in voltage resulting in eaw 177 (low battery) and eaw 128 (replace battery) warnings as well as a pump reboot event.Moisture was observed behind the display lens and inside the battery compartment.The returned battery cap was found to be undamaged and able to properly secure to the pump.During investigation, the battery compartment was found to be cracked from the thread area to the case seal and below the grip pad.A leak test was performed and a leak was identified in the battery compartment.The pump cover was opened and moisture was observed throughout the internal components.The pump¿s electrical draws were tested and¿ found not to be within required specifications.The observed high current draw levels were found to be due to moisture contamination.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7522930
• Report Number: 2531779-2018-09251
• Device Sequence Number: 1176286
• Product Code: OYC
• UDI-Device Identifier: 10840406100341
• UDI-Public: 10840406100341
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2018

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
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Initial Date Received by Manufacturer: 05/05/2018
• Supplement Date Received by Manufacturer: 05/05/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 60