MAUDE Adverse Event Report: MEDTRONIC MINIMED 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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2016
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that his insulin pump had received motor error every time he tried to bolus and also motor position encoder error.The customer's blood glucose level was unknown at the time of the incident.The customer was assisted in troubleshooting.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display due to corroded battery tube spring contact, corroded keypad traces and corroded battery tube.Unable to perform all functional testing including the operating currents, a21 error test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test or verify motor error alarm and e70 alarm due to blank display.Motor passed motor test.

• 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 MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8904641
• Report Number: 2032227-2019-48128
• Device Sequence Number: 2731262
• Product Code: OYC
• UDI-Device Identifier: 00613994904522
• UDI-Public: (01)00613994904522
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 04/06/2020

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-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A000202989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 138