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

Model Number	MMT-722NAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	08/19/2018
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 the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was over 300mg/dl at the time of the incident.The customer also reported that the insulin was squirting during manual prime process.The customer stated that the drive support cap was loose.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Unit powered up properly after the test battery was installed.No unexpected battery type alarms noted after battery insertion.Unit passed the displacement test, rewind, self test and unexpected restart error test.The stop current and run current measurement tests are within specification.Unit also passed off no power alarm test.Unit alarmed compromised force sensor system during prime test due to faulty force sensor resistor.Unable to perform the basic occlusion test, occlusion test, excessive no delivery test and the delivery accuracy test due to the compromised force sensor system alarm.Unit had intermittent button response on the esc and act buttons due to corroded keypad traces.Drive support disk was inspected and no anomaly was noted.No label anomaly noted.Unit had a missing motor drive support sticker.Unit also had minor scratched display window, cracked case at display window corner, cracked battery tube threads, cracked reservoir tube, cracked reservoir tube window and a partially broken off reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
• 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: 7867419
• Report Number: 2032227-2018-26731
• Device Sequence Number: 1720340
• Product Code: OYC
• UDI-Device Identifier: 00613994402035
• UDI-Public: (01)00613994402035
• 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): 10/05/2018

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Device Lot Number: A5722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 145