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

Model Number	MMT-723NAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump received with corroded battery tube, cracked battery tube thread, reservoir tube lip completely broken off, missing reservoir tube lip o-ring, cracked reservoir tube, cracked case near display window corners, cracked on display window and minor scratches on display window noted.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Drive support cap was inspected and no anomaly was noted.
Event or Problem Description
The health care professional reported via phone call that insulin pump got the over delivery.The blood glucose at the time of the incident was unknown.The customer was assisted with troubleshooting.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 7544191
• Report Number: 2032227-2018-03887
• Device Sequence Number: 233410
• Product Code: OYC
• UDI-Device Identifier: 00643169077706
• UDI-Public: (01)00643169077706
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A000269477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• 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