MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
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	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No button error alarm noted during testing.Unit had unresponsive esc and act buttons due to unlocked j2/lcd keypad connector.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.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
The customer reported via phone call that the insulin pump buttons were not responding.The customer¿s blood glucose level was 159 mg/dl at the time of the incident.Customer was advised to observe time clock for one minute to verify if time advances and they stated that the time was advances.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8442928
• Report Number: 2032227-2019-02454
• Device Sequence Number: 16865818
• Product Code: OYC
• UDI-Device Identifier: 00643169221543
• UDI-Public: (01)00643169221543
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/22/2019

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A000207238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 163