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

Model Number	MMT-751LNAB
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump passed the rewind, basic occlusion, prime/a33 and displacement test.Pump received with stuck motor error alarm loop during bolus delivery.The motor was tested outside of the device and passed.The motor may have had and intermittent failure that was not detected during our testing.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump received motor error alarm.Customer stated that the drive support cap was normal and insulin pump was not exposed to high magnetic field.Customer did not report about motor position encoder error alarm.Customer was able to clear the alarm and able to complete insulin pump rewind.Customer stated that the alarm history contains more than one motor error within 30 days.Customer also stated that the insulin pump received no delivery alarm.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAB
• 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; * 00777-3869
• MDR Report Key: 10031573
• Report Number: 2032227-2020-114379
• Device Sequence Number: 2986027
• Product Code: OZO
• UDI-Device Identifier: 00643169507746
• UDI-Public: (01)00643169507746
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/06/2020

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-751LNAB
• Device Catalogue Number: MMT-751LNAB
• Device Lot Number: A4751LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 260