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

Model Number	MMT-523NAL
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Connection Problem (2900); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	03/01/2020
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¿s mother reported via phone call that customer went passed out.Customer stated battery compartment and reservoir openings were damaged and the reservoir was not staying in the insulin pump.Customer stated insulin pump was over delivering.Troubleshooting was performed.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the rewind test, prime or a33 test and excessive no delivery test.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Unable to perform the displacement test, basic occlusion test, occlusion test and delivery accuracy test due to completely broken off reservoir tube lip.Unable to verify possible over delivery anomaly due to completely broken off reservoir tube lip.The test p-cap and reservoir will not lock in place in the reservoir compartment due to completely broken off reservoir tube lip.Device also had a missing reservoir tube o-ring, broken battery tube threads and a missing end cap sticker.Device uploaded properly using care link.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• 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: 9823474
• Report Number: 3004209178-2020-84307
• Device Sequence Number: 3129851
• Product Code: OYC
• UDI-Device Identifier: 00643169202320
• UDI-Public: (01)00643169202320
• 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,Followup
• Report Date (Section B): 03/20/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: A9523NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Weight: 34