MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAH
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/14/2020
Type of Reportable Event	Malfunction
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 and also received button error alarm.The customer¿s blood glucose level was 402 mg/dl.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Additional information has been received which was not included with the initial report.The information has been provided with this report.
Event or Problem Description
It was reported that the insulin pump had blank display.
Additional Manufacturer Narrative
Device monitored for several days and no blank display noted.Device received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Device received with normal operating current.Device passed self test.Device passed off no power test.No frozen screen noted during test and time clock advances properly.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9858420
• Report Number: 2032227-2020-101955
• Device Sequence Number: 2373222
• Product Code: OYC
• UDI-Device Identifier: 00643169221529
• UDI-Public: (01)00643169221529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/19/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A000291727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 03/14/2020
• Supplement Date Received by Manufacturer: 04/19/2020; 05/18/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/27/2020; 05/19/2020
• 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-UNK-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 155