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

Model Number	MMT-522NAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/03/2017
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 button error alarm after being exposed to water.Blood glucose level at the time of the incident was 196 mg/dl.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Findings: no button error alarm.Unit received with no button response due to corroded act button keypad trace.The button keypad connector was found closed properly during visual inspection.Unable to perform functional test due to keypad anomaly.No moisture damage electronic or motor assembly.Unit had minor scratched lcd window, cracked case near display window corners, cracked battery tube threads, cracked reservoir tube lip, reservoir tube cracked, cracked reservoir tube window, missing end cap sticker and cracked lcd window.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
• 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: 6673866
• Report Number: 2032227-2017-24325
• Device Sequence Number: 1971286
• Product Code: OYC
• UDI-Device Identifier: 00613994622655
• UDI-Public: (01)00613994622655
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/28/2017

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-522NAS
• Device Catalogue Number: MMT-522NAS
• Device Lot Number: A6522NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 06/03/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 180