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	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	07/10/2020
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 they experienced diabetic ketoacidosis.The customer¿s blood glucose was 204 mg/dl and 300 mg/dl.The customer stated drive support cap was sticking out.The customer stated retainer ring was cracked and reservoir was able to lock in place.The customer declined troubleshooting for high blood glucose.Customer was unable to complete the rewind process on there insulin pump, customer stuck on fill tubing.Customer was reporting an issue during priming process.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with broken reservoir tube lip noted.The test reservoir p-cap was able to lock in place.Device passed displacement test.However, device alarmed a33 during basic occlusion test due to drive support disk sticking out noted.Unable to perform prime/a33 test, occlusion test and excessive no delivery test or verify prime/fill anomaly due to a33 alarms.

• 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: 10281381
• Report Number: 2032227-2020-147293
• Device Sequence Number: 689931
• Product Code: OZO
• UDI-Device Identifier: 00643169503656
• UDI-Public: (01)00643169503656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/13/2020

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: A4551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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: FRN-MMT-332-RSVR, UNOMED SET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 59