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

Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a history/settings (inaccurate delivery) issue.The reporter alleged the basal rates being delivered were not the same as what was programmed.The reporter alleged she did not change her basal rates.There was no indication that the product caused or contributed to an adverse event.This issue is being reported as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 01-may-2019 with the following findings: during investigation, a review of the total daily dose history showed incongruent dates, changing from (b)(6)2019 to (b)(6)2018.There was no data in the black box from these dates due to continued use of the pump.The daily insulin delivery totals appeared inconsistent due to the date changes.The pump history showed the pump was delivering programmed the basal rate until deliveries were halted by the user at 11:32 pm on (b)(6)2018.During testing, the pump successfully completed a rewind, load, and prime sequence.The pump passed the delivery accuracy testing and was found to be delivering within required specifications.All activity performed during testing was accurately recorded in pump history.The complaint of a history settings issue was not duplicated during investigation.There was no defect found.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.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7753545
• Report Number: 2531779-2018-14255
• Device Sequence Number: 1719806
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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: 04/25/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR