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

Model Number	MMT-723NAH
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/18/2020
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
Customer reported via phone call that they were hospitalized on may 18 due to hyperglycemia and diabetic ketoacidosis.Customers blood glucose level was 580 mg/dl at the time of hospitalization.Customer has been using insulin pump system within 48 hours of reported high blood glucose level.Customer declined troubleshooting.Customer experienced symptoms such as short of breath and vomiting.Customer was treated with intravenous fluid and insulin drip.Customer declined to perform a carelink upload.Customer stated that drive support was flush.Customer reported that insulin pump had motor error and tried rewinding but did not work.The insulin pump will be returned for analysis while the reservoir will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion test, prime/a33 test, excessive no delivery test, self test, a21 error test and the delivery accuracy test at 0.08740 inches.All operating currents are within specification.Off no power alarm functions properly.No rewind anomaly noted.Device alarmed motor error during occlusion test due to faulty force sensor resistor.The motor was tested outside of the unit and passed.Drive support disk was inspected and no anomaly was noted.Device had scratched case, broken belt clip slot, scratched reservoir tube window, cracked reservoir tube lip and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 10091095
• Report Number: 2032227-2020-122691
• Device Sequence Number: 19668703
• Product Code: OYC
• UDI-Device Identifier: 00613994743909
• UDI-Public: (01)00613994743909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/22/2020

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-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A3723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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-MMT-332-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 31 YR
• Patient Weight: 170