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

Model Number	MMT-522NAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
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 they were hospitalized due to high blood glucose and sugar was over 507mg/dl.The current blood glucose level was 347mg/dl.The customer experienced symptom such as vomiting.The customer was treated with manual injection.Customer got alarm for alarmed compromised force sensor system during priming.Troubleshoot did not resolve the issue.The customer was wearing the insulin pump during the hospitalization.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
All operating currents are within specification.No unexpected low batt or off no power alarms noted.Unit alarmed compromised force sensor system during basic occlusion test due to loose/protruded drive support disk.Unable to complete functional test due to compromised force sensor system alarm.Unit received with cracked case on display window corners, minor scratched lcd window, cracked reservoir tube window corners, cracked reservoir tube window, cracked reservoir tube lip, cracked belt clip slot, cracked battery tube threads and stained resilient lcd cover.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 6880367
• Report Number: 2032227-2017-50663
• Device Sequence Number: 16348741
• Product Code: OYC
• UDI-Device Identifier: 00613994402110
• UDI-Public: (01)00613994402110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A5522NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 09/10/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 190