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

Medical Device Problem Codes	Moisture Damage (1405); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.The pump has been returned and evaluated by product analysis on 24-sep-2018 with the following findings: device evaluation: on investigation, the battery compartment was noted to be cracked with moisture corrosion in the battery compartment due to moisture ingress confirmed on leak testing.The pump had additional moisture damage in the interior compartment and the pump failed to power on during the investigation.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.
Event or Problem Description
The pump was returned for investigation.Investigation revealed a case/condition with moisture and no power issue.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 # 2531779-2018-18184.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8316634
• Report Number: 2531779-2019-00982
• Device Sequence Number: 1649891
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 08/14/2018

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: 09/13/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 21 MO
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• 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: 8 YR