MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAB
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The insulin pump was received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to perform all functional testing including the operating currents, unexpected error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test or verify charge/battery lasts less than expected anomaly, rewind anomaly, no delivery alarm and failed battery test due to blank display.Pump received with broken belt clip slot and minor scratched lcd window.
Event or Problem Description
The customer reported via phone call that the insulin pump's belt clip was broken, there were scratches on the insulin pump, battery life was diminished at 3 weeks, insulin pump had rejected new batteries, had no delivery alarms necessitating site change, insulin pump rewinding seemed to be taking longer and insulin pump squirted out insulin during priming instead of dripping.The customer's blood glucose level was unknown.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
• 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: 9227513
• Report Number: 2032227-2019-108466
• Device Sequence Number: 16547024
• Product Code: OYC
• UDI-Device Identifier: 00643169446434
• UDI-Public: (01)00643169446434
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 10/23/2019

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-723NAB
• Device Catalogue Number: MMT-723NAB
• Device Lot Number: B3723NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 101