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 Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Fever (1858); Hyperglycemia (1905); Unspecified Infection (1930); Nausea (1970); Vomiting (2144); Ulcer (2274)
Date of Event	07/23/2020
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 emergency medical services was dispatched, they were in emergency room and hospitalized due to hyperglycemia, diabetic ulcer and an infection from (b)(6) 2020.The customer¿s blood glucose level was 542 mg/dl at time of incident.Another blood glucose level was 167 mg/dl.The customer was assisted with troubleshooting.The customer was treated with insulin pump.The customer stated that the symptoms related to high blood glucose such as fever, nausea and vomiting.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The insulin pump had motor error alarm.Customer was able to successfully clear the alarm.Customer was able to complete pump rewind.The device will not be returned for analysis.
Additional Manufacturer Narrative
Device received with constant a35 alarm during the rewind test due to motor encoder signal out of phase.Unable to complete the functional test, including the displacement test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, delivery accuracy test, the stop current and run current measurement tests, self test, off no power alarm test and a21 error test due to constant a35 alarm.Unable to verify motor error alarm due to a35 alarm.Used a test motor to clear the a35 alarm in order to perform the care link upload.Device had cracked case at display window corner, cracked battery tube threads and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.

• 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
• MDR Report Key: 10337490
• Report Number: 2032227-2020-154432
• Device Sequence Number: 3748793
• 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,Followup
• Report Date (Section B): 09/22/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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 INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 46 YR
• Patient Weight: 180