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

Model Number	MMT-523LNAH
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	06/17/2019
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer's parent reported via phone call that the insulin pump had button error.The customer¿s blood glucose level was 88 mg/dl.Customer reported that the act button of the insulin pump was unresponsive.The customer was advised to discontinue the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
No button error alarm noted during testing.Device had intermittent buttons response due to flattened (creased) act button dome switch.No unlocked lcd keypad connector noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH
• 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: 8774638
• Report Number: 2032227-2019-27500
• Device Sequence Number: 16638677
• Product Code: OYC
• UDI-Device Identifier: 00643169932951
• UDI-Public: (01)00643169932951
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A5523LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 28