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 Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/01/2018
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 they were hospitalized due to ketoacidosis and high blood glucose with blood glucose of 407 mg/dl, current blood glucose was 366 mg/dl.Time and date of hospitalization was (b)(6) 2018 on 12 pm.Assisted with performing the hp test and test results did not alarm.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
(b)(4).The insulin pump was received with the operating currents within spec.And passed the self test, unexpected restart error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test, and the dat test at 0.08775 inches.The no delivery alarm functioned properly and audio alarm could be heard during the basic occlusion and occlusion tests.The information provided in the section of concomitant product with the initial report was incorrect.The correct information has been included with this report.

• 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: 8149959
• Report Number: 2032227-2018-73365
• Device Sequence Number: 10825919
• Product Code: OYC
• UDI-Device Identifier: 00643169077706
• UDI-Public: (01)00643169077706
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 12/27/2018

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: A6723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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, UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 35 YR
• Patient Weight: 167