MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/01/2017
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.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 they went to the emergency room on (b)(6) 2017 at 7:00 a.M.Due to high blood glucose.They had tried treating with a bolus but it would not go down.The customer¿s blood glucose level during the incident was 400 mg/dl.The customer¿s blood glucose level at the time of admission was 250 mg/dl.It was noted that their health care professional changed the program setting of the insulin pump.The device will be returned for analysis.
Additional Manufacturer Narrative
Findings; pump received with the reservoir tube lip partially broken and reservoir tube missing the o-ring.A test reservoir was installed and did not lock in place due to broken reservoir tube lip.Pump received with normal operating currents and passed the self test, displacement test, rewind, unexpected alarm error test, prime test, and the excessive no delivery test.Unable to perform the basic occlusion test, occlusion test, and the dat test due to broken reservoir lip.Pump received with partially broken reservoir tube lip, reservoir tube missing o-ring, cracked battery tube threads, case cracked at the display window corner, minor scratched lcd window, stained lcd resilient cover, scratched reservoir tube window, case cracked at the reservoir tube window corner, and reservoir tube window cracked.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• 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: 6757221
• Report Number: 2032227-2017-32832
• Device Sequence Number: 1411727
• Product Code: OYC
• UDI-Device Identifier: 00613994904287
• UDI-Public: (01)00613994904287
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/20/2017

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: A5523NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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
• Patient Age: 68 YR
• Patient Weight: 148