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 called and alleged that an error 1 message occurred and could not be cleared.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
Follow-up #1: date of submission 10/17/2017 the pump has been returned and evaluated by product analysis on 09/25/2017 with the following findings: a review of the black box and pump history showed no activity related to the complaint.Error 1 alarms were found in the meter history.The pump and meter powered up normally and paired successfully.The pump and meter ran for 24 hours and no issues occurred.Periodic boluses were executed successfully.The error 1 complaint was unable to be duplicated during the investigation.Unrelated to the original complaint, the display was dim with a red hue.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.

• 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: 6796451
• Report Number: 2531779-2017-18310
• Device Sequence Number: 855800
• Product Code: LZG
• UDI-Device Identifier: 00353885010207
• UDI-Public: 0100353885010207
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 08/09/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 10/17/2017
• 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: 57