MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722RNAH
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
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.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call the insulin pump alarmed compromised force sensor system.Customer blood glucose reading was 94 mg/dl.The drive support is flushed.The alarm occurred while changing the reservoir.Customer stated insulin keep squirting out and could not rewinding and priming process.The insulin pump will be returning for analysis.
Additional Manufacturer Narrative
Device passed displacement test.However, device alarmed compromised forced sensor system alarm during basic occlusion test due to slightly loose drive support disk.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAH
• 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: 7815705
• Report Number: 2032227-2018-17633
• Device Sequence Number: 1175618
• Product Code: OYC
• UDI-Device Identifier: 00613994623904
• UDI-Public: (01)00613994623904
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/03/2018

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-722RNAH
• Device Catalogue Number: MMT-722RNAH
• Device Lot Number: A000142627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 200