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

Medical Device Problem Codes	Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
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 27-sep-2019 with the following findings: a review of the pump black box showed cs 078 call service alarms.During testing, during rewind step the pump emitted a cs 078 call service alarm.There was moisture observed on the display.The pump was found to leak at a crack in the case.The pump was opened and moisture damage found on motor flex connector, causing the alarm.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 01-aug-2019, the reporter contacted animas, alleging a call service alarm (cs 078) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because this 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: 9125609
• Report Number: 2531779-2019-04892
• Device Sequence Number: 14107018
• Product Code: LZG
• UDI-Device Identifier: 10840406101010
• UDI-Public: 10840406101010
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: 08/26/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR