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

Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging multiple random error one messages were emitted while using the meter remote.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may lead to a delay in treatment due to an inability to obtain blood glucose readings.
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 09/28/2017 with the following findings: a review of the meter history showed an error1 sub code 17.During testing, the meter remote was powered on and immediately paired successfully with a test pump to complete investigation.No errors were duplicated during testing.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6857180
• Report Number: 2531779-2017-20874
• Device Sequence Number: 108565
• Product Code: LZG
• UDI-Device Identifier: 00353885010207
• UDI-Public: 0100353885010207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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: 08/31/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR