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

Model Number	MMT-523RNAS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 the insulin pump alarmed motor error and high blood glucose event.The customer¿s blood glucose level was 373 mg/dl at the time of the incident.The customer stated that the drive support cap was normal and that the insulin pump was exposed to high magnetic fields and was able to complete the rewind process.Customer had a high blood glucose of 554 mg/dl and treated with manual injection.Customer declined high blood glucose troubleshooting.The customer was advised to 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.
Additional Manufacturer Narrative
Device received with normal operating currents and passed the self-test, unexpected restart error test, displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test.No motor error alarms, unexpected excessive no delivery alarms, or displacement anomalies noted.The motor was tested outside the device and passed.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• 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: 7759965
• Report Number: 2032227-2018-10426
• Device Sequence Number: 11188857
• Product Code: OYC
• UDI-Device Identifier: 00613994748706
• UDI-Public: (01)00613994748706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 11/23/2018

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-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000167945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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: 84 YR
• Patient Weight: 92