MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2018
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 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
Customer reported via phone call that insulin pump alarmed compromised force sensor system and squirting out during manual prime.Drive support cap was sticking out.Customer¿s blood glucose was 150mg/dl at time of incident.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The device received compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.No moisture damage on electronics and motor assembly noted.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 7341290
• Report Number: 2032227-2018-01951
• Device Sequence Number: 16339874
• Product Code: OYC
• UDI-Device Identifier: 00613994223685
• UDI-Public: (01)00613994223685(017)20091231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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 Expiration Date: 12/31/2009
• Device Model Number: MMT-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A000093859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 195