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

Model Number	MMT-551RNAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/23/2017
Type of Reportable Event	Serious Injury
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that they experienced high blood glucose level of 590 mg/dl.He took 20 units of insulin and his blood glucose was not coming down.The customer also had blood glucose of 480 mg/dl.Customer stated he took a long walk and his blood glucose was around 270 mg/dl.Customer stated his sensor glucose was reading 400 mg/dl.When the customer got home around 6 pm, his meter said it was too high to test.Customer then took 12 units of insulin and and then 8 more units of insulin.Customer's blood glucose last time he checked was 450 mg/dl.The customer¿s current blood glucose was 423 mg/dl.The customer treated with bolus from insulin pump.The drive support cap was normal.The product was not returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551RNAL PRDGM CLEAR RECERT
• 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: 7105318
• Report Number: 2032227-2017-71776
• Device Sequence Number: 10958153
• Product Code: OZO
• UDI-Device Identifier: 00643169507937
• UDI-Public: (01)00643169507937
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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
• Device Model Number: MMT-551RNAL
• Device Catalogue Number: MMT-551RNAL
• Device Lot Number: A3551RNALJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 12/11/2017
• 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: Other
• Patient Age: 69 YR
• Patient Weight: 98