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

Model Number	MMT-551LNAP
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump passed the displacement test but motor error alarm during the basic occlusion test due to protruded drive support disk.Unable to perform the occlusion, prime and excessive no delivery alarm due to motor error alarm.Motor passed motor test.Pump received with cracked battery tube threads, partial broken reservoir tube lip and cracked case reservoir tube window corner.The p-cap locks into the reservoir compartment properly noted.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a motor error alarm as well as no delivery alerts.The customer mentioned that the device was slower to rewind and cracks on top of screen.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Updated with additional information and the initial report was submitted with wrong aware date 'date received by mfr'.The correct date is 14-sep-2020.
Event or Problem Description
Information received by medtronic indicated that the insulin pump slower to rewound and crack on top of screen.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.Updated summary: information received by medtronic indicated that the insulin pump had motor error alarm in the last 3 weeks but there was no issue with rewind process.Customer was also getting no delivery alarm.Customer stated there was a scratch and crack on the device.

• Brand Name: 530G INSULIN PUMP MMT-551LNAP
• 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: 10538282
• Report Number: 2032227-2020-177305
• Device Sequence Number: 4016549
• Product Code: OZO
• UDI-Device Identifier: 00643169507722
• UDI-Public: (01)00643169507722
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/16/2020

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-551LNAP
• Device Catalogue Number: MMT-551LNAP
• Device Lot Number: A4551LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 160