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

Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
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 and alleged that the patient experienced a blood glucose of 11 mg/dl associated with an inaccurate delivery issue.Reportedly, the patient discontinued the insulin pump, emergency protocol was initiated and the patient was treated by ems with glucagon injection.Troubleshooting was unable to be completed at the time of the call.This complaint is being reported based on the allegation against the delivery function of the pump.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 12/09/2016 with the following findings: on review of the download history, the daily insulin delivery totals appear inconsistent.Product analysis was not able to investigate the alleged inaccurate delivery issue because the pump was received in a condition that prevented investigation of the complaint.

• 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: 6033562
• Report Number: 2531779-2016-28764
• Device Sequence Number: 672968
• Product Code: LZG
• UDI-Device Identifier: 10840406100808
• UDI-Public: 0110840406100808
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/23/2016

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: 11/29/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 12/30/2016
• 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: Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 199