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

Medical Device Problem Code	Device Issue (2379)
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.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) 2016, the reporter contacted animas, alleging an unusual issue.It was reported that ¿the pump is on its way out¿.Attempts to reach the reporter for further details and clarification were unsuccessful.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is an allegation of the device not working per specifications.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 18-dec-2017 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten.The pump powered up with the returned battery cap to a dim and discolored display.The battery cap was unable to fully tighten.The battery compartment was cracked in the thread area and below the grip pad.No evidence of moisture contamination was found in the battery compartment.The cartridge compartment was damaged along the top.A test cartridge cap was fully secured.The pump was run for 24 hours and no reboots, power losses, or call service alarms were duplicated.The pump case was removed to find no evidence of moisture or loose components.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6123526
• Report Number: 2531779-2016-32072
• Device Sequence Number: 1154674
• Product Code: LZG
• UDI-Device Identifier: 10840406101126
• UDI-Public: 0110840406101126
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2016

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: 12/13/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: 10/28/2016
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 165