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

Model Number	MMT-722NAH
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	05/27/2011
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with compromised force sensor alarm during displacement test due to excessive axial play.Unable to verify motor error alarm.Unable to perform displacement test due to compromised force sensor alarm.
Event or Problem Description
Customer's mother reported via phone call that the insulin pump had button not responding.The blood glucose at the time of the incident was 137 mg/dl.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH
• 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: 7951013
• Report Number: 2032227-2018-40301
• Device Sequence Number: 1499293
• Product Code: OYC
• UDI-Device Identifier: 00613994622587
• UDI-Public: (01)00613994622587
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/10/2018

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-722NAH
• Device Catalogue Number: MMT-722NAH
• Device Lot Number: A2722NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2011
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR