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 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/ moisture) issue.The reporter alleged moisture was 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
Device evaluation: the pump has been returned and evaluated by product analysis on 18-jun-2018 with the following findings: a review of the pump¿s black box showed evidence of short battery life illustrated with a voltage drop leading to a cs128 alarm on (b)(6) 2018.The returned battery cap was undamaged and able to fit securely.There was evidence of moisture corrosion observed in the battery canister; a leak test failed due a battery compartment leak.The ez-prime steps were performed correctly; the pump alarmed with cs177 warning upon confirming verify screen.All currents reading were found to be within specification.The complaint of the reported short battery life complaint and moisture in the pump was duplicated.The pump¿s cover was removed and no further moisture ingress or other damage to the printed circuit board was found.

• 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: 7541424
• Report Number: 2531779-2018-09716
• Device Sequence Number: 1794470
• Product Code: OYC
• UDI-Device Identifier: 10840406100273
• UDI-Public: 10840406100273
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 05/17/2018

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: 06/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 185