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) 2017 the reporter contacted animas, alleging a power (battery life w/ moisture) issue.Moisture was reported to be present 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 user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission 01-feb-2018 device evaluation: the device has been returned and evaluated by product analysis on 19-jan-2018 with the following findings: a review of the pump black box data indicated no evidence of short battery life.Multiple cs 128 alarms occurred.During a visual inspection of the pump, the battery compartment was observed to be cracked.There was evidence of moisture contamination observed in the battery canister.A leak test failed due a battery compartment leak.The returned battery cap was undamaged and secured properly to the pump with no power loss.Current draws measured within specifications.The pump case was removed and no evidence of moisture ingress or loose components was found.The complaint of a battery life issue was not duplicated during investigation.

• 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: 7191931
• Report Number: 2531779-2018-00993
• Device Sequence Number: 13492307
• Product Code: OYC
• UDI-Device Identifier: 10840406100013
• UDI-Public: 10840406100013
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 12/21/2017

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: 01/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR