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

Model Number	MMT-751RNAS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit alarmed motor error during basic occlusion test due to faulty.Unable to perform basic occlusion test, occlusion test, prime or compromised forced sensor system test, excessive no delivery test or verify no reservoir alarm due to motor error alarm.However, unit passed rewind test and displacement test.Motor passed motor test.
Event or Problem Description
Customer reported via phone call that the insulin pump had motor error.Customer¿s blood glucose level was unknown at the time of incident.Customer did not report an e70 alarm.Customer stated that the drive support cap appears to be normal.Customer stated that the insulin pump passed the displacement test and manual prime test and the motor error alarm did not reoccur.Advised the insulin pump will need to be replaced.Advised to discontinue use of the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751RNAS
• 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: 8720973
• Report Number: 2032227-2019-19425
• Device Sequence Number: 1729959
• Product Code: OZO
• UDI-Device Identifier: 00643169508002
• UDI-Public: (01)00643169508002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/20/2019

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-751RNAS
• Device Catalogue Number: MMT-751RNAS
• Device Lot Number: A3751RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 208