MAUDE Adverse Event Report: ANIMAS LLC ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has been returned and evaluated by product analysis on 24-sep-2018 with the following findings: the battery compartment was cracked below the bumper pad.(b)(6).
Event or Problem Description
The pump was returned for investigation.Investigation revealed the battery compartment was cracked.This report is made based on results of investigation completed on 24-sep-2018.
Additional Manufacturer Narrative
Follow-up #1: date of submission 25-feb-2019 - please note, the report submitted on 02/07/2019 is a duplicate report, and was submitted in error, as the reportable investigation findings for this complaint were already included in the fda q3 2018 summary report, submitted to the fda on 10/11/2018, under report # 2531779-2018-18179.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8318240
• Report Number: 2531779-2019-01103
• Device Sequence Number: 13865500
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 09/20/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 154