MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Visual Prompts will not Clear (2281); Obstruction of Flow (2423); Power Problem (3010); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Information received by medtronic indicated that the insulin pump buttons were hard to press.Customer stated that the insulin pump had random no delivery alarms.Insulin pump was squirting insulin during prime process.Insulin pump had rejected new batteries.Insulin pump had locked up and was unresponsive.No harm requiring medical intervention was reported.The device will be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to partial unlocked lcd keypad connector noted during visually inspect.Unable to perform all functional testing including the displacement, operating currents, a21 error test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery alarm or verify failed battery alert, prime/fill anomaly and frozen display anomaly due to buttons not responding.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB
• 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: 10117670
• Report Number: 2032227-2020-126068
• Device Sequence Number: 16682603
• Product Code: OYC
• UDI-Device Identifier: 00643169513051
• UDI-Public: (01)00643169513051
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/24/2020

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-523RNAB
• Device Catalogue Number: MMT-523RNAB
• Device Lot Number: A1523RNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR