MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551NAH
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call that they did high pressure test on the insulin pump and it was failed and did not get any alarm for no delivery.Customer¿s blood glucose level was high of 253 mg/dl since sunday night.Customer did not called back to perform high pressure test.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer felt ok to troubleshooting high blood glucose level.Customer wished to continue insulin pump troubleshooting for possible causes of high blood glucose.Customer was explained the two high blood glucose rule.Customer was advised to change entire set, reservoir and insulin and treat per healthcare professional's instructions.Customer was advised to call back for assistance if high blood glucose persist.The insulin pump was returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9096177
• Report Number: 2032227-2019-65894
• Device Sequence Number: 11429034
• Product Code: OZO
• UDI-Device Identifier: 00643169736023
• UDI-Public: (01)00643169736023
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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 Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A6551NAHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 160