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 Code	Hyperglycemia (1905)
Date of Event	08/26/2017
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 reported via phone call the insulin pump would not exit the preparing to prime screen and alarmed compromised force sensor system error.The customer¿s blood glucose level was 600 mg/d at the time of the incident.Customer treated with manual injection for the high blood glucose level.Customer states that they have dropped the insulin pump before getting the alarms.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump was received with loose/protruded drive support disk, minor scratched display window, cracked case at display window corners, cracked battery tube threads, broken reservoir tube lip, cracked belt clip slot, and missing end cap sticker.Compromised force sensor system alarm during basic occlusion test due to loose/protruded drive support disk.Insulin pump passed idle current test, run current test, displacement test and rewind.Unable to perform self-test, off no power test, unexpected restart error test, occlusion test, prime/compromised force sensor system test, and excessive no delivery test due to compromised force sensor system alarm.

• 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: 6864943
• Report Number: 2032227-2017-48043
• Device Sequence Number: 18858828
• Product Code: OYC
• UDI-Device Identifier: 00613994748737
• UDI-Public: (01)00613994748737
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/08/2018

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-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000168688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 08/26/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 01/08/2018
• 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: 67 YR
• Patient Weight: 188