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

Model Number	MMT-551PNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (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 she experienced a high blood glucose level of 400 mg/dl.The customer's current blood glucose was 398 mg/dl and it was also the same reading at the time of the incident.Customer stated that she has not treated yet.The recent high blood glucose event began on (b)(6) 2017.Troubleshooting was performed and air bubbles were found along the tubing length.Customer stated that the insulin exited at the quick release.Customer was advised that positioning in the motor may have shifted.The air bubbles were not successfully removed.Customer was advised to do a complete set change to resolve the no delivery and air bubble issue.Customer also reported that she had a bent sensor.Customer was advised that the sensor may not be working or may be damaged.The reservoir and the sensor will be returned for analysis.The insulin pump will not be returned.

• Brand Name: 530G INSULIN PUMP MMT-551PNAH
• 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: 6658946
• Report Number: 2032227-2017-22564
• Device Sequence Number: 188352
• Product Code: OZO
• UDI-Device Identifier: 00643169507272
• UDI-Public: (01)00643169507272
• 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): 06/21/2017

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-551PNAH
• Device Catalogue Number: MMT-551PNAH
• Device Lot Number: A3551PNAHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2017
• Initial Report FDA Received Date: 06/21/2017
• 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: 59 YR
• Patient Weight: 196