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) 2019, the reporter contacted animas, alleging a other (unusual issue) issue.The reporter alleged that the cartridge was not able to be fully loaded into the pump and the cartridge protrudes from the cartridge complaint.No further information was provided.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long-term cessation of insulin delivery if the user is unable to resolve the cartridge loading issue.
Additional Manufacturer Narrative
Device analysis: the device was returned to the manufacturer and investigation completed on (b)(4) 2019 with the following findings: on investigation, product analysis was unable to duplicate the complaint regarding the cartridge protruding from the cartridge compartment.The cartridge cap that was returned with the pump was able to fully tighten and hold the cartridge in place.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8213998
• Report Number: 2531779-2019-00039
• Device Sequence Number: 19339278
• Product Code: LZG
• UDI-Device Identifier: 10840406101058
• UDI-Public: 10840406101058
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 01/02/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR