MAUDE Adverse Event Report: ANIMAS LLC ANIMAS INSULIN CARTRIDGE; INSULIN PUMP CARTRIDGE

Lot Number	D200487
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 a site/set/cart (air bubbles/leak) issue.The reporter alleged the patient experienced elevated blood glucose measuring 389 mg/dl with lethargy while on insulin pump therapy.This combination of blood glucose level and symptom does not meet animas¿ criteria of a reportable adverse event.Therefore, no adverse event is being reported in associated with this complaint.The reporter alleged the development of air bubbles in the insulin cartridge after the cartridge was loaded into the pump and further reported the strong odor of insulin inside the cartridge compartment, alleging the cartridge was leaking insulin.Animas customer support completed troubleshooting of the cartridge issue with the reporter and determined there was no use error involved and the cartridge had been prepared by the user according to the instructions for use.The subject cartridge was discarded by the user and not available to be returned to the manufacturer for investigation.This complaint is being reported because the presence of air bubbles in the cartridge or leakage can result in under delivery.

• Brand Name: ANIMAS INSULIN CARTRIDGE
• Common Device Name: INSULIN PUMP CARTRIDGE
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8531343
• Report Number: 2531779-2019-02720
• Device Sequence Number: 13819517
• Product Code: LZG
• UDI-Device Identifier: 10840406100129
• UDI-Public: 10840406100129
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 04/18/2019

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
• Device Lot Number: D200487
• 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: 04/18/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR