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

Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, the reporter contacted animas and alleged the patient was hospitalized.No other information was provided.The reporter was unwilling/unable to troubleshoot the pump.Animas made multiple attempts to contact the reporter.This complaint is being reported as the pump could not be eliminated as a cause contributor to the hospitalization.
Additional Manufacturer Narrative
Follow-up #1: device evaluation: the device has been returned and evaluated by product analysis on 03/06/2017 with the following findings: the recorded total daily doses of insulin added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing with no delivery defects found.The pump was found to be delivering within required range.No delivery interruptions or alarms occurred during the investigation.

• 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: 6240567
• Report Number: 2531779-2017-00918
• Device Sequence Number: 891139
• Product Code: LZG
• UDI-Device Identifier: 10840406101126
• UDI-Public: 0110840406101126
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/24/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 29 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 22 YR
• Patient Weight: 120