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

Model Number	MMT-723RNAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/05/2018
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 customer reported via phone call the insulin pump alarmed motor error.The customer¿s blood glucose level was 308 mg/dl at the time of the incident and treated with manual injection.Customer reported that the insulin pump alarmed motor error after possible exposure to mri.The customer stated that the drive support cap was normal and that the insulin pump could have been exposed to high magnetic fields.Customer reported a motor position encoder error.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
Pump passed the rewind, basic occlusion, prime and displacement test.Pump was received with stuck motor error alarm loop during bolus delivery.The motor was tested outside of the device and passed.The motor may have had an intermittent failure that was not detected during our testing.Unable to confirm the motor position encoder error alarm due to erased history file.Pump had cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip, cracked reservoir tube window, cracked case at reservoir tube window corner, belt clip slot, minor scratched display window, stained end cap sticker and stained address/serial number label.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 7276720
• Report Number: 2032227-2018-01522
• Device Sequence Number: 1847579
• Product Code: OYC
• UDI-Device Identifier: 00613994904393
• UDI-Public: (01)00613994904393
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000204715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 253