MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAL
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
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.Insulin pump received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the unexpected restart error test, prime/compromised force sensor system test, excessive no delivery test and occlusion test due to motor error alarm.Pump received with normal operating current.Pump passed self test.Pump passed off no power test.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.
Event or Problem Description
Customer reported via phone call on (b)(6) 2018 that the buttons of the insulin pump are hard to press and may have worn out.Customer's blood glucose level was unknown at the time of the incident.The customer also reported issues with battery longevity and random no delivery alarms.Troubleshooting did not occur.Product will not return for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 8747630
• Report Number: 2032227-2019-23214
• Device Sequence Number: 13875520
• Product Code: OYC
• UDI-Device Identifier: 00613994402110
• UDI-Public: (01)00613994402110
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/01/2019

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-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A5522NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR