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

Model Number	MMT-723LNAB
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/09/2020
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 were treated by emergency medical services as they had low blood glucose level.Customer¿s blood glucose level was 24 mg/dl, at the time of incidence.Customer reported that they treated with glucagon and food.Customer reported that the insulin pump delivered large amount of insulin over night to them and they had low blood glucose level.Customer declined to troubleshoot for low blood glucose level.It was unknown if the customer was using auto mode at the time of event.The insulin pump and reservoir will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08740 inches.No over delivery anomaly or under delivery anomaly noted.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.Device had intermittent button response on the esc button due to flattened dome switch.No button error alarm noted.During visual inspection, the keypad connector on the lcd board was found locked properly.Device uploaded properly using care link.Device had cracked battery tube threads, scratched reservoir tube window and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.The over delivery anomaly was not specified in the customer notes.Unable to verify over delivery anomaly.However, from analyzing the daily insulin total usage a week prior to the event date, there was no anomaly noted.The daily insulin totals were between 66 unit to 73 units with the exception on (b)(6) 2020 was only basal delivery.There was no obvious increase of insulin used.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB
• 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: 10306680
• Report Number: 2032227-2020-150549
• Device Sequence Number: 19675746
• Product Code: OYC
• UDI-Device Identifier: 00643169513877
• UDI-Public: (01)00643169513877
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/09/2020

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-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A5723LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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 SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 181