MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAP
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/07/2018
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
The customer reported via phone call that the insulin pump alarmed compromised force sensor system.Customer experienced a high blood glucose and the high blood glucose level was 308 mg/dl.Customer treated with shot for high blood glucose.Customer stated that the drive support cap was normal.The customer decline troubleshooting for high blood glucose.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Compromised force sensor system alarm during basic occlusion test due to loose/protruded drive support disk.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAP
• 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: 7743600
• Report Number: 3004209178-2018-98797
• Device Sequence Number: 16541366
• Product Code: OYC
• UDI-Device Identifier: 00613994372048
• UDI-Public: (01)00613994372048
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 12/04/2018

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-522NAP
• Device Catalogue Number: MMT-522NAP
• Device Lot Number: A4522NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/07/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 08/02/2018
• 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: 17 YR
• Patient Weight: 119