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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/12/2018
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.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 experienced diabetic ketoacidosis and high blood glucose.The customer¿s blood glucose level was 338 mg/dl.The customer declined troubleshoot for high blood glucose.The device will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 8 open/used reservoirs.Inspected reservoirs, snap-cap, and septum for anomalies, none were found.Ran occlusion test as follows: reservoir filled with diluent and connected to a new infusion set.Installed reservoirs & connector into a paradigm pump, performed pump manual prime, saw fluid flow through infusion set and out catheter tip.Conclusion: reservoirs not occluded.Also, inspected 6 of 8 reservoir¿s snap-caps width dimension per (b)(4).Also, using a new lab infusion sets connect found reservoir's snap-caps too loose to connect/lock.2 remaining's checked reservoirs using a new lab infusion set.Found reservoirs easy to connected/release.No connector anomalies were observed during analysis.(b)(4).

• 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: 7844160
• Report Number: 2032227-2018-22735
• Device Sequence Number: 11154327
• Product Code: OYC
• UDI-Device Identifier: 00643169693753
• UDI-Public: (01)00643169693753
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/06/2018

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: B5523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 115