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

Model Number	MMT-751LNAH
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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
Information received by medtronic indicated that the insulin pump received compromised forced sensor alarm during rewinding and priming.Customer reported the drive support cap was normal.The force sensor was no longer detecting reservoir during seating.No harm requiring medical intervention was noted.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to perform prime or a33 test, excessive no delivery test and occlusion test or verify a33 alarm due to motor error alarm.Device received with cracked belt clip slot, missing end cap sticker, stained address or serial number label and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.

• Brand Name: 530G INSULIN PUMP MMT-751LNAH
• 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: 10377810
• Report Number: 2032227-2020-159414
• Device Sequence Number: 3167876
• Product Code: OZO
• UDI-Device Identifier: 00643169507753
• UDI-Public: (01)00643169507753
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Device Lot Number: A4751LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2021
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 86