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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.(b)(4).
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had been hospitalized with hyperglycemia.The reporter stated that the patient had a blood glucose of 500 mg/dl with symptoms of large ketones, thirst, urination, and vomiting.The patient was receiving intravenous fluids and insulin via injections while at the hospital.The reporter stated that there was an issue with the pump¿s time and date settings causing the patient to receive programmed night time basal rates during the day and daytime basal rates at night.During troubleshooting it was determined that the pump was powering on to the verify screen for the date and time.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event as a result of the improper time being selected in the pump.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7880583
• Report Number: 2531779-2018-16875
• Device Sequence Number: 1939621
• Product Code: LZG
• UDI-Device Identifier: 10840406100990
• UDI-Public: 10840406100990
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/27/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/17/2018
• 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: 13 YR