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

Model Number	MMT-723LNAL
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/24/2020
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
The customer reported via phone call that they experienced high blood glucose.Blood glucose reading went up to 500 mg/dl.Customer was treated with insulin.Customer reported that insulin pump had motor error alarm during rewind.Customer stated that they were able to clear alarm and able to complete rewind process.Customer stated that insulin pump had button error alarm.Customer declined to troubleshoot for high blood glucose.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to flattened (no creased) dome switch on esc, act, up arrow and down arrow button.J2 connector was inspected and locked on lcd board.No button error alarm during testing.Device passed displacement test, rewind test, basic occlusion test, prime/a33 test, excessive no delivery test, self test and occlusion test, no motor error alarm during testing noted.The motor was tested outside the unit and passed.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 10217136
• Report Number: 2032227-2020-139759
• Device Sequence Number: 19470905
• Product Code: OYC
• UDI-Device Identifier: 00643169933156
• UDI-Public: (01)00643169933156
• 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): 07/20/2020

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A6723LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/20/2020
• 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 INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Weight: 170