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 Codes	Mechanical Problem (1384); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/29/2020
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 reported via phone call that they had hyperglycemia.Blood glucose level was over 600 mg/dl and they treated with insulin pump.Customer reported that the insulin pump had motor error alarm and no delivery alarm.Troubleshooting was done for motor error alarm.Drive support cap was normal.Customer was able to clear the alarm and able to rewind insulin pump.Customer did displacement test and it was successful and motor error did not recur.Customer declined to troubleshooting for no delivery alarm and said they were familiar with no delivery alerts and will change out infusion set.Customer declined to troubleshooting for high blood glucose.The insulin pump will be returned for analysis.

• 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; * 00777-3869
• MDR Report Key: 10371550
• Report Number: 2032227-2020-158375
• Device Sequence Number: 19536485
• Product Code: OYC
• UDI-Device Identifier: 00643169513105
• UDI-Public: (01)00643169513105
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: A1723RNABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/06/2020
• 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: UNOMED INF SET, FRN-MMT-332-RSVR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 68