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

Model Number	MMT-551NAP
Medical Device Problem Codes	Failure to Cycle (1142); Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/03/2019
Type of Reportable Event	Serious Injury
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 phone call that the customer experienced hyperglycemia as well as insulin pump had compromised force sensor system alarm.Customer¿s blood glucose level was 409 mg/dl at the time of incident and fasting 170 mg/dl.Customer was treated with syringe.Customer stated that she took four units but believes insulin was not delivered.Customer stated that they were unable to exit the preparing to prime loop.Customer stated that the drive support cap was normal.Troubleshooting was performed for insulin pump error alarm.The insulin pump will be returned for analysis and reservoir will not be returned for analysis.
Additional Manufacturer Narrative
Device received unable to perform all functional testing including the displacement, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test or verify a33 alarm and possible under delivery due to completely broken reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-551NAP
• 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: 9283292
• Report Number: 2032227-2019-113616
• Device Sequence Number: 14044073
• Product Code: OZO
• UDI-Device Identifier: 00643169404281
• UDI-Public: (01)00643169404281
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A3551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 11/03/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 150