MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722LNAH
Medical Device Problem Codes	No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the insulin pump was died and had a blank display.The customer¿s blood glucose level was unknown at the time of the incident.The customer was assisted with troubleshooting and declined for blank display.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 per healthcare professional instructions.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and delivery accuracy test at 0.08730 inches.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device powered up properly after the test battery was installed.Device was monitored for 4 days.No blank display anomaly or unexpected battery power loss anomaly noted.Device uploaded properly using carelink.No damage noted on the lcd glass.Device had minor scratched display window, cracked display window, scratched case, cracked case at display window corner, cracked battery tube threads, missing end cap sticker 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-722LNAH
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8132132
• Report Number: 2032227-2018-70908
• Device Sequence Number: 10805047
• Product Code: OYC
• UDI-Device Identifier: 00613994597236
• UDI-Public: (01)00613994597236
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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-722LNAH
• Device Catalogue Number: MMT-722LNAH
• Device Lot Number: A000139231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 73