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

Medical Device Problem Codes	Partial Blockage (1065); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Dyspnea (1816); Lethargy (2560); Polydipsia (2604)
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) 2019, the reporter alleged the pump was emitting occlusion alarms and the patient discontinued insulin pump therapy due to the occlusion alarms and not having another infusion set to connect to because she needed to change out the infusion set.During troubleshooting with animas customer support, it was discovered the patient was using the infusion set for longer than instructed by the manufacturer per the instructions for use (four days instead of the advised three-day maximum) and the patient was also re-using the insulin cartridges, which is against the manufacturer¿s instructions for use.These actions constitute a training/misuse issue on the part of the patient.The reporter stated the patient alleged that after having discontinued insulin delivery with the insulin pump as described above, they experienced elevated blood glucose of 370 mg/dl with additional symptoms of dyspnea, polydipsia and polyuria, nausea, lethargy and additional symptoms suggestive of dehydration.The patient reportedly provided self-treatment ¿per usual method.¿ the reporter confirmed the patient did not receive treatment over or above the usual routine of diabetes care and management.No further details were provided.This complaint is being reported because the patient reportedly experienced hyperglycemia while off of insulin pump therapy due to repeated occlusion alarm with identified 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: 8745132
• Report Number: 2531779-2019-03783
• Device Sequence Number: 19167951
• 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?: Yes
• 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
• Patient Age: 17 YR
• Patient Weight: 82