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

Model Number	MMT-723LNAH
Medical Device Problem Codes	Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364); Blood Loss (2597)
Date of Event	07/02/2020
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¿s mother and husband reported that customer was hospitalized due diabetes ketoacidosis and high blood glucose on (b)(6) 2020.Blood glucose level at the time of the incident was over 404 mg/dl.Customer stated that they were hospitalized due to an insulin pump malfunction.Customer stated that the insulin pump did not alarm or indicate an issue, customer went to bed and woke up vomiting.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer¿s husband took customer to emergency room and was treated with intravenous drip and dextrose and saline administration.Customer does not allege insulin pump was under delivering.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The information provided related to event date and hospitalization date with the initial report was incorrect.The correct information has been included with this report.(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¿s mother and husband reported that customer was hospitalized due diabetes ketoacidosis and high blood glucose on (b)(6) 2020.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: 10248838
• Report Number: 2032227-2020-143538
• Device Sequence Number: 10899660
• Product Code: OYC
• UDI-Device Identifier: 00643169513884
• UDI-Public: (01)00643169513884
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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): 07/23/2020

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-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A5723LNAHJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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-MMT 332A-RSVR, UNOMED SET, OZP-MMT-7020A-SNSR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 11 YR