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	Fatigue (1849); Blurred Vision (2137); Dizziness (2194)
Date of Event	01/14/2020
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.(b)(4).
Event or Problem Description
On (b)(6) 2020, the reporter contacted animas alleging that the patient experienced a blood glucose of 267 mg/dl with increased urination, increased drowsiness, increased thirst and blurred vision associated with a loss of prime issue.Reportedly, the patient remained on the pump and was treated with 4 units of insulin administered by the patient's husband.During troubleshooting with customer technical support (cts), it was noted that patient was using expired cartridges.It was also noted that the patient had a subsequent low blood glucose of 39 mg/dl with dizziness and being unsteady on feet after husband administered 4 units of insulin.This pi is being reported due to the patient experiencing an adverse event as a result of user error from the patient using expired cartridges.

• 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: 9612507
• Report Number: 2531779-2020-00025
• Device Sequence Number: 16824723
• Product Code: LZG
• UDI-Device Identifier: 10840406100129
• UDI-Public: 10840406100129
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 01/14/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/21/2020
• 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: Required Intervention
• Patient Age: 71 YR