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

Model Number	MMT-723RNAH
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/16/2017
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 had low blood glucose of 58 mg/dl.The customer also received multiple insulin pump errors and drive support cap was flushed.Their current blood glucose was 48 mg/dl.Low blood glucose was treated with juice and food.Customer stated that the insulin pump has stopped working.It says no power and insulin pump error and there are two long lines with a vertical bar inside.The rest of the insulin pump is dark and it starts counting up.Customer stated that, the healthcare professional changed her basal the other day and she was high this morning and treated with insulin and then treated with a little more insulin.Based on customer report customer does not allege pump was over delivering.Customer declines to continue troubleshoot.Customer stated that, the insulin pump had off no power alarm.Customer stated that, they did not receive a low battery alert prior to the off no power alert.Customer stated that, there were not unattended alarms.Assisted customer in reviewing alarm history.Alarm occurred during the rewind and prime sequence.Customer advised to replace and refer to back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with spi to motor pic communication error followed by off no power alert, problem isolated to mother board.Unable to perform any tests due to spi to motor pic communication error and off no power alert.Device received with cracked battery tube thread, broken belt clip slot, cracked reservoir tube lip and minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
• 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: 7154535
• Report Number: 2032227-2017-78259
• Device Sequence Number: 1888091
• Product Code: OYC
• UDI-Device Identifier: 00613994904416
• UDI-Public: (01)00613994904416
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/20/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723RNAH
• Device Catalogue Number: MMT-723RNAH
• Device Lot Number: A000248627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/16/2017
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 06/20/2018
• 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: 76 YR
• Patient Weight: 54