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

Model Number	MMT-523NAP
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/19/2018
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 the customer was hospitalized due to hyperglycemia on end of january with blood glucose level was 500 mg/dl, 423 mg/dl at time of incident and the current blood glucose level was 161 mg/dl.The customer was assisted with troubleshooting.The customer was treated with insulin pump and manual injection.Customer was using insulin pump system within 48 hours of reported high blood glucose event.The customer stated that the symptoms related to high blood glucose such as nausea.Customer alleges that the insulin pump was under delivering because there has been cracked on the insulin pump.Customer states that the drive support cap appears normal.Customer stated insulin exited at the quick release.Customer stated that the insulin pump was dropped few times and had crack starting on right corner of the screen up to the case about three quarter of an inch and also crack on the screen of the reservoir compartment.Customer stated the reservoir was able to lock in place when inserted into insulin pump.The device will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received unable to perform the displacement, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test due to completely broken reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 8109801
• Report Number: 2032227-2018-67917
• Device Sequence Number: 1630603
• Product Code: OYC
• UDI-Device Identifier: 00643169446410
• UDI-Public: (01)00643169446410
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: B3523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVRUNOMED INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 44 YR
• Patient Weight: 150