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); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/23/2018
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.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 via phone call that they had experienced high blood glucose and insulin pump received motor error.The customer¿s blood glucose level was 501 mg/dl.The customer reported that they received a motor error alarm and changed the battery and was not able to rewind.Customer was able to successfully clear the alarm.Customer was able to complete pump rewind.The customer reported that the drive support cap was normal.The customer was advised the pump will need to be replaced.The customer was advised to discontinue use of the pump and was advised to refer to back up plan, per health care professional instructions.The insulin pump will not be returned for analysis.

• 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: 8202832
• Report Number: 2032227-2018-80177
• Device Sequence Number: 1656804
• Product Code: OYC
• UDI-Device Identifier: 00643169077706
• UDI-Public: (01)00643169077706
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/28/2018

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/28/2018
• 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-UNK-RSRVR, UNOMED UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 81