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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Urinary Frequency / Polyuria (2275)
Date of Event	05/09/2017
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) 2017, the reporter contacted animas and alleged that on (b)(6) 2017, the patient experienced a blood glucose of 586 mg/dl with polyuria, large ketones and vomiting associated with an inaccurate delivery issue.Reportedly, the patient remained hospitalized with diabetic ketoacidosis and was treated with insulin via injection and iv fluids.During troubleshooting with customer technical support (cts), it was revealed that the basal and bolus totals matched the patient¿s programmed settings and that all were recorded as programmed.The patient was able to deliver one unit via air bolus while on the phone with cts which was recorded correctly in the pump¿s history.Cts determined that an issue with the quality of insulin contributed to the bg excursion; however, it was also revealed that the patient only changed their cartridge every 4-5 days against instructions for use.This complaint is being reported because the patient allegedly experienced hyperglycemia while on the insulin pump.

• 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: 6608415
• Report Number: 2531779-2017-11740
• Device Sequence Number: 16436772
• Product Code: LZG
• UDI-Device Identifier: 10840406101126
• UDI-Public: 0110840406101126
• 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
• Report Date (Section B): 05/11/2017

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?: No
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/02/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 72