MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAH
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/27/2019
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 visited to emergency room then hospitalized due to high blood glucose on last end of may to july with blood glucose of 300 mg/dl to 450 mg/dl.The customer was treated with drip.Troubleshooting was done for high blood glucose and under delivery.Customer reported that the up and down buttons were hard to got a response and battery compartment was cracked.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, self test and a21 error test.The stop current and run current measurement tests are within specification.Device also passed off no power alarm test.Device was unable to prime during prime/a33 test due to cracked end cap.Unable to perform the basic occlusion test, occlusion test, excessive no delivery test and the delivery accuracy test due to prime anomaly.All buttons function properly.No damage noted on the keypad traces.No button error alarm noted.During visual inspection, the j2 keypad connector on the lcd/b was found locked properly.Device uploaded properly using carelink.Device had cracked battery tube threads, cracked reservoir tube and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 10122229
• Report Number: 2032227-2020-126588
• Device Sequence Number: 2925297
• Product Code: OYC
• UDI-Device Identifier: 00643169507173
• UDI-Public: (01)00643169507173
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/12/2020

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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: B4523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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 SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 35 YR
• Patient Weight: 61