MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/07/2020
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 call that the customer had high blood glucose level of 455 mg/dl.Customer was treated with insulin pump.Customer was alleging insulin pump for under delivering because customer did bolus still customer had high blood glucose level.Customer had blood glucose levels of 140, 301, 331, 317,362, 319, 315, 180, 179, 205 and 291 mg/dl.Customer stated that the drive support cap was normal.Customer declined to check air bubbles and leak.Customer was using insulin pump system within 48 hours of reported high blood glucose level event.The insulin pump will be returned for analysis.Frn-unk, unomed set.
Additional Manufacturer Narrative
Device received with all operating currents within specification and passed functional testing including the rewind, a21 error test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.No possible under delivery anomaly noted.Device was downloaded to care link pro properly and all bolus delivered were found at the care link report.Device passed the delivery accuracy test at 0.0873 inches.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 10095149
• Report Number: 2032227-2020-123241
• Device Sequence Number: 19663429
• Product Code: OYC
• UDI-Device Identifier: 00643169513082
• UDI-Public: (01)00643169513082
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/10/2020

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A1523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 130