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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 04-feb-2019 with the following findings: during investigation, there were reboots observed in the black box.There was no damage found to the battery cap or to the battery compartment.The battery cap was able to attach securely to the pump.The pump powered on normally with no alarms.There were no power issues during testing.The battery cap contacts were all within specification.The pump was opened and there was no damage found to the power circuit.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas, alleging a power (intermittent power) issue.It was alleged that the pump went back to the verification screen without the user pressing anything.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the user may be unaware that the pump has lost power, leading to 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: 8550903
• Report Number: 2531779-2019-02804
• Device Sequence Number: 2358651
• Product Code: LZG
• UDI-Device Identifier: 10840406101058
• UDI-Public: 10840406101058
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 12/30/2018

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: 01/08/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2018
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR