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	11/15/2017
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 was assisted with troubleshooting and the display did not return.Customer blood glucose have been high.Customer has been using insulin pens.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Pump received with blank display due to moisture damage at electronic assembly.Also, moisture damage motor during visual inspection.Unable to perform operating currents, self test and displacement test due to blank display.Pump received with minor scratched lcd window, cracked belt clip slot, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.

• 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: 7073063
• Report Number: 2032227-2017-69428
• Device Sequence Number: 1132448
• Product Code: OYC
• UDI-Device Identifier: 00613994622693
• UDI-Public: (01)00613994622693
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/20/2018

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: A6522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 165