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

Medical Device Problem Codes	Premature Discharge of Battery (1057); 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
Device evaluation: the device has been returned and evaluated by product analysis on 28-oct-2019 with the following findings: a review of the pump's alarm history showed low battery warnings.The pump information from the date of the original complaint has been overwritten.During investigation, the pump's electrical draws were tested and were found to be within specifications.Investigation revealed the battery compartment was cracked.A leak test was performed and a leak was found at the battery compartment.There was evidence of moisture corrosion in the battery compartment only.No other components of the pump showed evidence of moisture.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.This complaint was previously included in the voluntary summary report submission (vmsr) and is now being submitted as an initial report with investigation findings due to the transition of the vmsr program.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (battery life with damage/moisture) issue.It was alleged the battery compartment was cracked with moisture behind the display.There was no indication that this issue lead to an adverse event.This 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.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 9273075
• Report Number: 2531779-2019-05985
• Device Sequence Number: 18872892
• Product Code: LZG
• UDI-Device Identifier: 10840406100976
• UDI-Public: 10840406100976
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• 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
• Report Date (Section B): 05/31/2018

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: 10/22/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 0 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR