MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAH
Medical Device Problem Codes	No Display/Image (1183); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump received with minor scratched lcd window, broken battery tube threads, cracked lcd window, cracked case at the display window corner, cracked reservoir tube window and cracked case at the reservoir tube window corner.Insulin pump received with all no button response due to flattened button dome switch and partial unlocked lcd keypad connector noted during visual inspect.Unable to verify unexpected low battery alarm, blank display, rewind anomaly, excessive no delivery alarm, e code errors and perform all functional tests, including the idle current measurement test, run current measurement test, self test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime, compromised force sensor system test, rewind test and excessive no delivery test due to no button response.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.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 their insulin pump had a unresponsive buttons.The customer¿s blood glucose level was unknown.Customer reported that the insulin pump had random no delivery alarm.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 8398722
• Report Number: 3004209178-2019-64267
• Device Sequence Number: 420103
• Product Code: OYC
• UDI-Device Identifier: 00643169446397
• UDI-Public: (01)00643169446397
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: B3523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 73