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

Model Number	MMT-523RNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/05/2018
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
Customer reported via phone call that they experienced high blood glucose level.The customer had not reported any symptoms and was treated with injections.Customer's blood glucose value was 346 mg/dl at time of incident.Customer's current blood glucose value was 89 mg/dl.Customer stated that they had highs and everything looks good and there does not appear to be air in his air bubbles.Troubleshooting was performed.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose.Customer stated that pump is under delivering and is treating for high blood glucose level and the blood glucose level wont not go down even while entering in extra insulin already changed insulin vial and checked set.The drive support cap appeared normal.Customer declined to check for the presence of leaks or air bubbles in the tubing/reservoir.Customer declined to check for possible site/insulin issues.Customer was explained about the 2 high blood glucose rule.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The product was not returned for analysis.
Additional Manufacturer Narrative
Pump passed all functional testing including the displacement, operating current, unexpected restart error test, rewind, basic occlusion test, occlusion test, prime, excessive no delivery test and passed the delivery accuracy test.Pump received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, cracked reservoir tube lip, cracked case display window corner, stained end cap sticker, stained address/serial number label, cracked belt clip slot and cracked case reservoir tube window corner.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB
• 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: 7204664
• Report Number: 3004209178-2018-44608
• Device Sequence Number: 904937
• Product Code: OYC
• UDI-Device Identifier: 00643169476462
• UDI-Public: (01)00643169476462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAB
• Device Catalogue Number: MMT-523RNAB
• Device Lot Number: A0523RNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 151