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	05/31/2017
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
It was reported that the customer received emergency medical assistance due to low blood glucose on (b)(6) 2017, with blood glucose of 54mg/dl at the time of the incident.The customer was able to get their reading as high as 62 mg/dl.The customer used carbs to treat.The customer was not wearing the insulin pump during the incident within less than 48 hours.Troubleshooting was completed and the nurse believes that the pump was over delivering.The customer completed a set change on monday evening and woke up tuesday morning and the pump had given all but 20 units.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump was received with all operating currents within spec and passed functional testing including the rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, self test, unexpected restart error test, delivery accuracy test and displacement test.The insulin pump delivered properly all bolus programmed during testing.The insulin pump was monitored for 2 days and no unexpected delivery of bolus anomaly noted.The insulin pump was received with cracked case at the display window corners, display window, reservoir tube, reservoir tube lip, battery tube threads and belt clip slot.Unit received with minor scratched display window and case.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• 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: 6624173
• Report Number: 2032227-2017-20881
• Device Sequence Number: 1305874
• Product Code: OYC
• UDI-Device Identifier: 00613994904416
• UDI-Public: (01)00613994904416
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/10/2017

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-723RNAH
• Device Catalogue Number: MMT-723RNAH
• Device Lot Number: A000204714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 200