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 Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Itching Sensation (1943)
Date of Event	07/31/2020
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's family member reported via phone call that the customer experienced hyperglycemia.The customer current blood glucose level was 600 mg/dl.Customer other blood glucose was 522 mg/dl.The customer was assisted with troubleshooting.Customer stated the site fills itchy, site from last night.The customer was treated with manual injection as well bolus for high blood glucose.Customer ate some pizza last night, she bloused, blood glucose did not go back down.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer stated that they did alleging insulin pump for under delivery because she boluses and keeps going high.Customer stated that they drive support cap was normal.Customer stated insulin exited at the quick release.Customer states the cannula was not bent.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test but a33 alarm during the basic occlusion test due to protruded drive support disk.Unable to perform the occlusion, prime or a33 and excessive no delivery test or verify under delivery anomaly due to a33 alarm.

• 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: 10372559
• Report Number: 2032227-2020-158949
• Device Sequence Number: 16868492
• Product Code: OYC
• UDI-Device Identifier: 00643169513082
• UDI-Public: (01)00643169513082
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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?: 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: 08/10/2020
• Initial Date Received by Manufacturer: 08/01/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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 SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 77