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

Model Number	10543400
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 17-jan-2020 with the following findings: during a visual inspection of the pump, the battery compartment was observed to be cracked from the threads to the case seal.The battery cap threads were stripped.The cap was unable to secure to the pump due to stripped cap threads.A test battery cap was able to tighten enough to the cracked compartment in order to power on the pump.Using the test cap, the pump was exercised for 12 hours with no power issues.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.This complaint was previously included in the voluntary summary report submission (vmsr) and is now being submitted as an initial report with investigation findings due to the transition of the vmsr program.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas, alleging a power (damage) issue.It was reported that the pump had intermittent power and the battery compartment was cracked.The battery cap was unable to be tightened.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because this issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 9636175
• Report Number: 2531779-2020-00045
• Device Sequence Number: 16836056
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 01/21/2020

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: 10543400
• Device Catalogue Number: 10543400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: Yes
• Device Age: 28 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR