MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAL
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/17/2019
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 was hospitalized due to hypoglycemia and insulin pump had compromised force sensor system.The customer¿s blood glucose level was 43 mg/dl at the time of incident.Customer was treated with glucose tablets.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.Customer reported the drive support cap appears normal.Customer was in emergency room as a result of low blood glucose.Customer did not allege insulin pump was over delivering.It was reported that during the last set change customer recalls insulin dripping or squirting from end of set before connecting at their site.Customer reported they have undergone 2 surgeries in the last month.Customer reports device was not worn during a medical procedure or tests around an mri.Customer¿s blood glucose as of now was 66 mg/dl.Customer reported that she was receiving a compromised force sensor system error on her mom's pump but she was using it and her mom gave it to her.Customer tried to change set but got error.Customer reported they were able to clear the alarm.Customer was not able to complete rewind.The devices will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 9229658
• Report Number: 2032227-2019-108504
• Device Sequence Number: 14050464
• Product Code: OYC
• UDI-Device Identifier: 00643169221482
• UDI-Public: (01)00643169221482
• 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
• Report Date (Section B): 10/23/2019

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-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000290380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/23/2019
• 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: Hospitalization
• Patient Age: 53 YR
• Patient Weight: 310