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

Model Number	10543100
Medical Device Problem Code	Failure to Sense (1559)
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.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.
Event or Problem Description
On (b)(6) 2020, the reporter contacted animas, alleging a prime (load step malfunction) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is the potential for insulin over delivery if the patient is not disconnected during the load cartridge step.The owner's booklet provides a warning to the user to never start the prime/rewind sequence on the pump while the infusion set is connected to the body and provides multiple reminders during the prime/rewind sequence.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 10129948
• Report Number: 2531779-2020-00122
• Device Sequence Number: 2116463
• Product Code: LZG
• UDI-Device Identifier: 10840406100976
• UDI-Public: 10840406100976
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 06/02/2020

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
• Device Model Number: 10543100
• Device Catalogue Number: 10543100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 35 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR