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

Model Number	MMT-523KNH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/05/2018
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
The caller reported via phone call the insulin pump had several motor error alarms and high blood glucose event.The customer¿s blood glucose level was 468 mg/dl at the time of the incident.The caller stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was able to complete the rewind process.Customer had a high blood glucose of 468 mg/dl and treated.No high blood glucose troubleshooting was performed.The caller was advised to have customer discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523KNH
• 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: 7365703
• Report Number: 2032227-2018-02146
• Device Sequence Number: 1097617
• Product Code: OYC
• UDI-Device Identifier: 00613994743756
• UDI-Public: (01)00613994743756
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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-523KNH
• Device Catalogue Number: MMT-523KNH
• Device Lot Number: A000170189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/23/2018
• 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: 7 YR
• Patient Weight: 42