MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751NAL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No rewind anomaly noted.Unit alarmed motor error during basic occlusion test due to faulty force sensor resistor (gold).Unable to perform basic occlusion test, occlusion test, prime, compromised force sensor alarm test, excessive no delivery test or verify no delivery alarm due to motor error alarm.However, unit passed rewind test and displacement test.Motor passed motor test.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.
Event or Problem Description
The customer reported via phone call that the insulin pump received motor error.The customer¿s blood glucose level was unknown.The customer reported that they received a motor error alarm and no delivery.Customer was unable to clear the alarm.Customer was unable to complete pump rewind.The customer reported that the drive support cap was normal.The customer was advised the pump will need to be replaced.The customer was advised to discontinue use of the pump and was advised to refer to back up plan, per health care professional instructions.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 8455293
• Report Number: 3004209178-2019-72771
• Device Sequence Number: 10851307
• Product Code: OZO
• UDI-Device Identifier: 00643169736085
• UDI-Public: (01)00643169736085
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A6751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 136