MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAS
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/10/2020
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 performed high pressure test and test was failed.The customer¿s blood glucose was 325 mg/dl.Customer reported that they experienced high blood glucose.Customer reported that they did not allege insulin pump was under delivering.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer treated with insulin pump and manual injection.Customer reported that the drive support cap appears normal.Customer reported the insulin pump was not worn during a medical procedure and test around magnetic resonance imaging.The customer was assisted with troubleshooting and declined for high blood glucose.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion test, self test and a21 error test.The stop (idle) current and run current measurement tests are within specification.Unit also passed off no power alarm test and the delivery accuracy test at 0.08765 inches.The no delivery alarm functions properly during the basic occlusion test.No unexpected no delivery alarm or battery out limit alarm noted during testing.Device powered up properly after the test battery was installed.Device was monitored for 1 day.No blank display or unexpected battery power loss anomaly noted.Device was unable to prime during prime test due to faulty force sensor resistor (gold).Unable to perform the occlusion test and excessive no delivery test due to prime anomaly.Device had minor scratched display window, scratched case, cracked battery tube threads, cracked reservoir tube, scratched reservoir tube window and cracked reservoir tube lip.Device passed the displacement test.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 9594560
• Report Number: 3004209178-2020-56232
• Device Sequence Number: 19457759
• Product Code: OYC
• UDI-Device Identifier: 00613994373083
• UDI-Public: (01)00613994373083
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A4722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 72