MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722RNAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	05/07/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that the customer experienced hypoglycemia as well as hyperglycemia.The customer¿s blood glucose level was 417 mg/dl at the time of incident and treated with manual injection and current blood glucose level was 61 mg/dl.The customer was assisted with troubleshooting.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer reports they have contacted their health care professional regarding the high blood glucose.Customer did not allege insulin pump was under delivering.Customer states the drive support cap appears normal.Customer declined to check their settings.Customer declined low blood glucose troubleshooting.The devices will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS
• 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: 8623221
• Report Number: 2032227-2019-04352
• Device Sequence Number: 2256650
• Product Code: OYC
• UDI-Device Identifier: 00613994409157
• UDI-Public: (01)00613994409157
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/20/2019

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-722RNAS
• Device Catalogue Number: MMT-722RNAS
• Device Lot Number: A000114517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/20/2019
• 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-MMT-332A-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 84