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

Model Number	MMT-523RNAL
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported via phone call that the insulin pump had a compromised force sensor system alarm.The customer¿s blood glucose level was unknown at the time of the incident.The customer stated that they filled the vile and when they started to fill it was rewinding.The customer was able to clear the alarm and was able to complete rewind.The customer was referred to the back-up plan as per the healthcare professional¿s instructions.The device will be returned for analysis.
Additional Manufacturer Narrative
Device received a33 alarm during basic occlusion test due to faulty force sensor resistor.Unable to perform basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test due to a33 alarm.However, device passed rewind test and displacement test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• 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: 9313879
• Report Number: 2032227-2019-116534
• Device Sequence Number: 2509472
• Product Code: OYC
• UDI-Device Identifier: 00643169221536
• UDI-Public: (01)00643169221536
• 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,Followup
• Report Date (Section B): 02/07/2020

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-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A000290552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 150