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

Model Number	MMT-751NAH
Medical Device Problem Codes	Obstruction of Flow (2423); Connection Problem (2900); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer reported via phone call that the cracked reservoir lip ring from reservoir area.The customer¿s blood glucose level was 300 mg/dl.Customer also reported that the insulin pump had received no delivery alarm.Troubleshooting was performed for damage and noticed the reservoir did not able to moves around.Customer was advised to the insulin pump will need to be replaced and to discontinue use of the insulin pump and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with intermittent button response due to flattened button dome switch and partial unlocked j2 or lcd keypad connector noted during visual inspect.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, compromised force sensor system and excessive no delivery test or verify no delivery alarm due to buttons not responding.Insulin pump received with cracked reservoir tube lip.No loose drive anomaly noted.

• Brand Name: 530G INSULIN PUMP MMT-751NAH
• 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: 8255990
• Report Number: 3004209178-2019-45844
• Device Sequence Number: 13932119
• Product Code: OZO
• UDI-Device Identifier: 00643169736078
• UDI-Public: (01)00643169736078
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/08/2019

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-751NAH
• Device Catalogue Number: MMT-751NAH
• Device Lot Number: A6751NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 130