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

Model Number	MMT-523RNAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/14/2017
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 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 was reported via phone call that, the customer received with unexpected restart alarm.Customer also reported with no delivery alarm during prime.Customer stated blood glucose when she get up was 500 mg/dl and something tried giving insulin and said no delivery no delivery alarm.The blood glucose was 519 mg/dl at eth time of the incident.The blood glucose was unknown at the time of the incident.Troubleshooting steps were guided for no unexpected restart alarm.Alarm occurred shortly after inserting a new battery.Customer received motor error after clearing the no delivery so went to troubleshoot for the no delivery.Customer was able to complete pump rewind.Customer stated she have not treated for high blood glucose will give shot with syringe.Customer declined high blood glucose troubleshooting.Customer reported that the drive support cap appears normal.The insulin pump should be discontinued since there was a motor error.The customer advised to replace the insulin pump.Customer advised to discontinue use of pump and refer to back up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test and unexpected restart error test.No motor error alarm, excessive no delivery alarms and unexpected restart error alarm noted.The motor was tested outside of the device and passed.Pump received with cracked battery tube thread, cracked reservoir tube lip, cracked reservoir tube, cracked case reservoir tube window corners, cracked case near display window corners, cracked on display window, stained end cap sticker and minor scratches on display window noted.Drive support cap was inspected and no anomaly was noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• 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: 7070975
• Report Number: 2032227-2017-69206
• Device Sequence Number: 799687
• Product Code: OYC
• UDI-Device Identifier: 00613994918635
• UDI-Public: (01)00613994918635
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/20/2018

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-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A000205308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 04/20/2018
• 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: 77 YR
• Patient Weight: 137