MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 had high blood glucose level.The customer¿s blood glucose level was 257 mg/dl to over 600 mg/dl.The customer reported that the infusion site of where the reservoir goes in the sealer was broken and it was hanging loose and the gasket was gone.The customer reported that the reservoir comes loose when on the insulin pump.The customer declined troubleshooting for high blood glucose level.Customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the insulin pump for analysis.
Additional Manufacturer Narrative
Device received unable to perform the displacement test due to complete broken reservoir tube lip noted.Received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, missing reservoir tube o-ring, cracked case display window corner, missing end cap sticker, stained address or serial number label, cracked belt clip slot, cracked reservoir tube window and cracked case reservoir tube window corner.The p-cap not locks into the reservoir compartment properly due to completely broken reservoir tube lip noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7364538
• Report Number: 2032227-2018-02135
• Device Sequence Number: 11256786
• Product Code: OYC
• UDI-Device Identifier: 00613994918635
• UDI-Public: (01)00613994918635
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/11/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A000205308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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: 86 YR
• Patient Weight: 113