MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAB
Medical Device Problem Codes	Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Ulcer (2274)
Date of Event	07/21/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported that emergency medical services were dispatched and was hospitalized due high blood glucose on (b)(6) 2020 to (b)(6) 2020.Blood glucose level at the time of the incident was over 500 mg/dl and when admitted to hospital was 542 mg/dl and then higher.Customer stated that had motor error alarms on the insulin pump.Customer stated that she was in the hospital and she took the insulin pump off during magnetic resonance imaging.Customer stated that they were nauseated, throwing up, temperature was 99°f then 102°f.Customer had a diabetic ulcer that led to an infection.Customer stated that she was treated in emergency room and admitted blood glucose 542 mg/dl and then higher and earlier at hospital it was blood glucose 167 mg/dl.Customer was able to successfully clear the alarm.Customer was able to complete insulin pump rewind.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer treated for high blood glucose with bolus and intravenous injection and admitted.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB
• 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; * 00777-3869
• MDR Report Key: 10348608
• Report Number: 2032227-2020-155434
• Device Sequence Number: 16743907
• Product Code: OYC
• UDI-Device Identifier: 00643169476561
• UDI-Public: (01)00643169476561
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 07/30/2020

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-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A0723RNABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: 46 YR
• Patient Weight: 82