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

Model Number	MMT-722NAS
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/28/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unit passed self test and displacement test.Pump received with intermittent button response due to corroded keypad traces.No button error alarm during testing.(b)(4).
Event or Problem Description
The customer reported via phone call that they were experiencing low blood glucose level.Blood glucose level at the time of the incident was 54 mg/dl.Customer was treated with carbohydrate.Customer stated insulin pump had button error alarm.Customer stated they did not holding a button down for 3 minutes or longer.Troubleshooting was performed.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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; * 00777-3869
• MDR Report Key: 10435336
• Report Number: 2032227-2020-166158
• Device Sequence Number: 14137685
• Product Code: OYC
• UDI-Device Identifier: 00613994402011
• UDI-Public: (01)00613994402011
• Combination Product (Y/N): N
• 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): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A5722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED INF SET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Weight: 66