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

Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 11-jul-2019 with the following findings: during investigation, it was found that the pump had visible moisture under the display lens.A leak test was performed and a leak was identified at the display lens.The pump cover was removed and internal moisture was found on the printed circuit board components causing the pump to be unresponsive.Report late due to transition from vmsr program.(b)(6).
Event or Problem Description
The pump was returned for investigation.Investigation revealed internal moisture damage to the printed circuit board causing the pump to be unresponsive.This report is made based on results of investigation completed on (b)(6) 2019.There was no indication that the product caused or contributed to an adverse event.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 9203888
• Report Number: 2531779-2019-05645
• Device Sequence Number: 19480362
• Product Code: LZG
• UDI-Device Identifier: 10840406100990
• UDI-Public: 10840406100990
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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
• Report Date (Section B): 07/11/2019

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: 07/10/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 35