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 device 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) 2019, the reporter contacted animas regarding a possible inaccurate delivery issue with the pump.The reporter did not provide any information regarding what the possible pump issue was.The reporter stated they could not stay on the phone with animas customer support because they had to tend to the patient who was experiencing low blood glucose.A blood glucose measurement was not provided to animas customer support; the reporter did not allege the patient experienced a serious injury associated with the use of the pump.Animas customer support requested the reporter call back to complete troubleshooting of the pump.Animas customer support made several subsequent attempts to complete troubleshooting of the device.However, during one successful contact with the patient, the patient stated they could not complete troubleshooting at the time.Animas customer support made an additional attempt to contact the patient to complete troubleshooting, but the patient has not responded.There is no indication the alleged product issue 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.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8386390
• Report Number: 2531779-2019-01671
• Device Sequence Number: 2053860
• Product Code: LZG
• UDI-Device Identifier: 10840406100990
• UDI-Public: 10840406100990
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 02/24/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR