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	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
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 that the insulin pump had a blank display.The customer¿s blood glucose level was unknown at the time of the incident.The customer called stating that he changed the battery and got a failed battery test, tried 4 different batteries and the issue continued.The customer stated that now the display screen will not come up at all and is now completely blank.The customer was assisted with troubleshooting and the display did not return.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test, self test and unexpected restart error test.The insulin pump passed all operating currents tested within the specification range and passed off no power test.The insulin pump was monitored and tested with no blank display and failed battery test noted.The insulin pump was received with cracked battery tube thread, broken reservoir tube lip, cracked case reservoir tube window corners, cracked reservoir tube window, cracked reservoir tube, cracked case near display window corners, bleeding lcd glass and minor scratches on display window noted.

• 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: 6870932
• Report Number: 2032227-2017-48816
• Device Sequence Number: 13765825
• Product Code: OYC
• UDI-Device Identifier: 00613994402127
• UDI-Public: (01)00613994402127
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/19/2018

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: A5522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 02/19/2018
• 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: 215