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
Health Effect - Clinical Codes	Hyperglycemia (1905); No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2017
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.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 that the insulin pump had a motor error alarm.Blood glucose level at the time of the incident was 474 mg/dl, which was treated with manual injection.Customer also reported a blood glucose level of 457 mg/dl.Blood glucose level at the time of the call was 182 mg/dl.Troubleshooting was not completed; the customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
Additional Manufacturer Narrative
Unit passed the displacement test, rewind, self test, off no power test, basic occlusion test and prime test.Unit received stuck in motor error alarm loop during bolus/basal delivery and motor position encoder error alarm noted in the alarm history screen.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 perform excessive no delivery test, unexpected restart error test and occlusion test due to motor error alarms.All operating currents are within specification.No unexpected low battery or off no power alarms noted.Drive support disk was inspected and no anomaly was noted.Unit received with cracked reservoir lip, minor scratched display window, cracked belt clip slot, cracked battery tube threads and stained end cap sticker.

• 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: 6615814
• Report Number: 2032227-2017-20740
• Device Sequence Number: 867133
• Product Code: OYC
• UDI-Device Identifier: 00613994748737
• UDI-Public: (01)00613994748737
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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: A000168688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/11/2017
• 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: 40 YR
• Patient Weight: 161