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

Medical Device Problem Code	Date/Time-Related Software Problem (2582)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump was returned for investigation and device evaluation was completed by product analysis on 06/20/2017 with the following findings: battery compartment crack near top left corner and lower left corner of grip pad.(b)(6).
Event or Problem Description
There was no adverse event associated with this complaint.The pump was returned for product analysis investigation and the evaluation revealed a cracked battery compartment.This report is made based on the results of an investigation completed on 06/20/2017.

• 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: 6718083
• Report Number: 2531779-2017-14968
• Device Sequence Number: 16466525
• Product Code: LZG
• UDI-Device Identifier: 10840406100808
• UDI-Public: 0110840406100808
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 06/20/2017

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: 05/24/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 33 MO
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 221