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

Model Number	MMT-522RNAS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
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.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
The customer reported via phone call that the insulin pump had an unexpected pump alarm during normal use.Blood glucose level at the time of the incident was 143 mg/dl.The customer stated that she was in a prime rewind loop.The customer stated she was trying to rewind the insulin pump and it keeps pushing out insulin and it kept doing it and then saw a compromised force sensor system alarm.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Findings: motor error alarm during the basic occlusion test due to faulty force sensor resistor.Unable to confirm compromised forced sensor alarm due to motor error alarm.Pump passed displacement test, self test and unexpected alarm error test.Pump passed all operating currents tested within the spec range and passed off no power test.Pump received with corroded battery tube, cracked reservoir tube lip, cracked reservoir tube and minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAS
• 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: 6845002
• Report Number: 2032227-2017-44780
• Device Sequence Number: 10884689
• Product Code: OYC
• UDI-Device Identifier: 00613994378866
• UDI-Public: (01)00613994378866
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/22/2017

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-522RNAS
• Device Catalogue Number: MMT-522RNAS
• Device Lot Number: A000112962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 141