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

Model Number	MMT-551PNAS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer reported via phone call that the insulin pump had motor error encoder position alarm.The customer¿s blood glucose level was 190 mg/dl.The customer stated that drive support cap was normal.The customer advise to discontinue use of the pump and recommended customer refer to back up plan, per hcp instructions.The device will be returned for the analysis.
Additional Manufacturer Narrative
Device passed rewind test, basic occlusion test, prime test and displacement test.However, device received stuck in the motor error loop during bolus or basal delivery and motor position encoder error alarm confirmed in the history file.The motor may have had an intermittent failure that was not detected during our testing.The motor was tested outside the device and passed.

• Brand Name: 530G INSULIN PUMP MMT-551PNAS
• 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: 8538537
• Report Number: 3004209178-2019-85814
• Device Sequence Number: 19265168
• Product Code: OZO
• UDI-Device Identifier: 00643169507302
• UDI-Public: (01)00643169507302
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 06/13/2019

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-551PNAS
• Device Catalogue Number: MMT-551PNAS
• Device Lot Number: A3551PNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 165