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

Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (battery life w/ damage) issue.It was reported that the battery compartment was cracked.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 a 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 23-aug-2018 with the following findings: a review of the black box showed evidence of a short battery life with a drastic voltage drop.The battery compartment was cracked from the threads down to the case seal on the side.The battery cap was not returned.A test battery cap was able to fit.Evidence of moisture corrosion was observed in the battery canister.A leak test failed due a battery compartment leak.The ¿ez-prime¿ steps were performed correctly and all current readings were within specifications.The ¿short battery life¿ allegation was unable to be duplicated.The pump cover was removed and no further moisture corrosion or any intermittent conditions were found to the power printed circuit board.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7788286
• Report Number: 2531779-2018-14986
• Device Sequence Number: 19126395
• Product Code: OYC
• UDI-Device Identifier: 10840406100310
• UDI-Public: 10840406100310
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR