MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970)
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.No conclusions can be made at this time.
Event or Problem Description
The reporter contacted animas on 25-jul-2019 alleging the patient experienced hyperglycemia while on insulin pump therapy evidenced by blood glucose measuring 599/mg/dl with large ketones, abdominal pain and nausea.The patient was reportedly hospitalized and received treatment of intravenous fluids and insulin via the pump.During troubleshooting with animas customer support, it was revealed that the patient¿s blood glucose elevated to 599 mg/dl after infusing 18 units of insulin that had been stored inside of a hot car via the pump.The reporter stated that the heated insulin that filled the cartridge was cloudy in appearance.This complaint is being reported because the patient experienced serious injury while on insulin pump therapy associated with training/misuse; not storing insulin per manufacturer instruction and using said insulin in the insulin pump for diabetes management.No product is being returned associated with this complaint; no complaint against the performance of the insulin pump.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8831747
• Report Number: 2531779-2019-04198
• Device Sequence Number: 14087573
• Product Code: OYC
• UDI-Device Identifier: 10840406100198
• UDI-Public: 10840406100198
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• 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): 07/25/2019

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: 32 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/26/2019
• 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: 21 YR
• Patient Weight: 119