MAUDE Adverse Event Report: ANIMAS LLC ANIMAS INSULIN CARTRIDGE; 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.Each cartridge lot is subjected to a statistical sampling plan and must pass testing for force (occlusion and loss of prime), cracks, and foreign material prior to release for distribution.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas alleging after they prime the pump, the cartridge starts to fill up with air.The patient reportedly experienced hyperglycemia with blood glucose ranging between 250-300 mg/dl with additional symptoms of small urinary ketones, abdominal pain, nausea, and tremors.The patient received telephone advise from their physician instructing them to drink lots of water.The basal settings were adjusted by the physician.Troubleshooting completed by animas customer support revealed the patient was filling the insulin cartridge with cold insulin out of the refrigerator without being brought to room temperature first as advised in the manufacturer's instructions for use.This complaint is being reported because the patient experienced a serious injury while on insulin pump therapy associated with user error.

• Brand Name: ANIMAS INSULIN CARTRIDGE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8745453
• Report Number: 2531779-2019-03785
• Device Sequence Number: 11332826
• Product Code: LZG
• UDI-Device Identifier: 10840406100129
• UDI-Public: 10840406100129
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032257
• 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): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/28/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 9 YR