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

Model Number	MMT-551NAL
Medical Device Problem Codes	Failure to Cycle (1142); Connection Problem (2900); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
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
The customer reported via that the insulin pump alarmed for compromised force sensor system during priming process.The customer¿s blood glucose level was 139 mg/dl.Customer reported that the drive support cap was protrude.Customer reported that the reservoir lip ring was break off and reservoir was not able to lock in place.Customer reported that during seating the force sensor did not detect the reservoir.The customer was advised to discontinued the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received unable to perform all functional testing including the displacement, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test or verify a33 alarm due to completely broken reservoir tube lip.Device received with broken reservoir tube lip, missing reservoir tube o ring and cracked battery tube threads.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-551NAL
• 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: 9479890
• Report Number: 2032227-2019-133761
• Device Sequence Number: 411449
• Product Code: OZO
• UDI-Device Identifier: 00643169404274
• UDI-Public: (01)00643169404274
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/05/2020

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-551NAL
• Device Catalogue Number: MMT-551NAL
• Device Lot Number: A3551NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 05/06/2020
• 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: 69