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

Medical Device Problem Code	Device Issue (2379)
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 for evaluation.An evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
Event or Problem Description
The reporter contacted animas on (b)(6) 2017 alleging the blood glucose meter was not holding combination bolus settings for factory default and split.Animas customer support performed troubleshooting with the reporter and confirmed that the settings were correct in the pump and that the pump and the meter were successfully paired.There was no indication the product caused or contributed to an adverse event.This complaint is being reported because the issue has the potential to contribute to long-term cessation of insulin pump therapy if the issue remains unresolved.
Additional Manufacturer Narrative
Follow-up #1: date of submission 10/18/2017 device evaluation: the device has been returned and evaluated by product analysis on 09/28/2017 with the following findings: a combo bolus with 20:80% was entered into the meter with a duration of 0.5hrs.After the combo bolus was completed, the meter correctly remembered the 20:80% split.The meter was found to be functioning normally.

• 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: 6819510
• Report Number: 2531779-2017-19183
• Device Sequence Number: 13469861
• Product Code: LZG
• UDI-Device Identifier: 00353885010207
• UDI-Public: 0100353885010207
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/26/2017

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: 08/11/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 180