MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722LNAP
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2019
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
Customer reported via phone call that the insulin pump had a button anomaly.Customer¿s blood glucose value was 265 mg/dl.Customer stated that the insulin pump was in pocket and started to alarm button error.Customer was advised to observe the time clock for one minute to verify if time was advance.Customer was advice to discontinue the use of the insulin pump and revert the backup plan as per health care professional.The device will not return for the analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Device passed self test.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP
• 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: 9346052
• Report Number: 2032227-2019-120002
• Device Sequence Number: 2734263
• Product Code: OYC
• UDI-Device Identifier: 00613994409546
• UDI-Public: (01)00613994409546
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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-722LNAP
• Device Catalogue Number: MMT-722LNAP
• Device Lot Number: A2722LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 250