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

Medical Device Problem Code	Structural Problem (2506)
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 a casing issue.The customer alleged that "there was a broken valve in the pump that prevented the pump from working properly." there was no allegation of an adverse event with this complaint.Customer support has made several attempts to contact the reporter in follow up, however, the reporter did not respond.No further information was available; if further information is provided a follow up report shall be made.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 23-september-2019 with the following findings: during investigation, there was no defect found in the casing of the pump.  investigation was unable to duplicate the original complaint of a casing/condition issue.  unrelated to the original complaint, the audio bolus button cover was lifted and the audio bolus button was  found to be inoperable.  the audio bolus button slug was found to be missing.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.

• 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: 6228523
• Report Number: 2531779-2017-00460
• Device Sequence Number: 464201
• Product Code: LZG
• UDI-Device Identifier: 10840406100815
• UDI-Public: 0110840406100815
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 12/15/2016

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
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR