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

Model Number	MMT-522NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/11/2017
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 reported via phone call the insulin pump alarmed motor error.The customer¿s blood glucose level was 180 mg/dl at the time of the incident.The customer reported that the drive support cap was protruded.Customer also reported that he had a high blood glucose of in the 300 mg/dl because he took the insulin pump off and used manual injection for treatment.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Motor error alarm during the basic occlusion test due to loose/flush drive support disk.Pump passed the displacement test.Unable to perform the prime/compromised force sensor system test, occlusion test and no delivery test due to motor error alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB
• 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: 7151480
• Report Number: 2032227-2017-77764
• Device Sequence Number: 1497007
• Product Code: OYC
• UDI-Device Identifier: 00613994372024
• UDI-Public: (01)00613994372024
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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-522NAB
• Device Catalogue Number: MMT-522NAB
• Device Lot Number: A4522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 210