MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723PNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723PNAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Customer reported via phone call that the insulin pump several issues.Customer¿s blood glucose was unknown at the time of incident.Customer reported that the insulin pump battery does not last long, damage to the battery compartment, had a failed battery test and button error alarm and the act button was hard to press.No troubleshooting was performed.Insulin pump is not expected to return for analysis.
Additional Manufacturer Narrative
Insulin pump passed displacement test, self test, unexpected restart error test, off no power test and all operating currents tested within the spec range.No unexpected low battery alarm were noted.Broken battery tube threads and missing end cap sticker noted.Insulin pump received with intermittent button response due to moisture damage to the keypad traces.No button error alarm during testing.
Additional Manufacturer Narrative
Insulin pump passed displacement test, self test, a21 error test, off no power test and all operating currents tested within the specific range.No unexpected low battery alarm were noted.Broken battery tube threads and missing end cap sticker noted.Pump received with intermittent button response due to moisture damage to the keypad traces.No button error alarm during testing.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723PNAB
• 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: 7642858
• Report Number: 2032227-2018-07620
• Device Sequence Number: 123957
• Product Code: OYC
• UDI-Device Identifier: 00613994748959
• UDI-Public: (01)00613994748959
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2019

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-723PNAB
• Device Catalogue Number: MMT-723PNAB
• Device Lot Number: A000169756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2019
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 03/11/2019; 08/16/2019
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 03/15/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 250