MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAS
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Environmental Compatibility Problem (2929); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/05/2020
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 customer experienced hyperglycemia and insulin pump had motor error alarm.The customer blood glucose level was 500 mg/dl.The customer was assisted with troubleshooting.The customer stated that drive support cap was normal.Customer stated that insulin pump was exposed to compute tomography scan.Customer stated that they received no delivery alarm.Customer was able to complete insulin pump rewind.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test.No excessive no delivery or occlusion alarm noted.No motor error alarm noted.Motor passed motor test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9686564
• Report Number: 2032227-2020-101039
• Device Sequence Number: 17062714
• Product Code: OYC
• UDI-Device Identifier: 00613994918611
• UDI-Public: (01)00613994918611
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/25/2020

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-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000204721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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-UNK-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 49