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

Model Number	MMT-723LNAL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/16/2018
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 that they had experienced high blood glucose and insulin pump received motor error.The customer¿s blood glucose level was 500 mg/dl.The customer reported that they received a motor error alarm and no delivery alarm.Customer was able to successfully clear the alarm.Customer was unable to complete pump rewind.The customer declined troubleshooting for high blood glucose.The customer reported that the drive support cap was normal.The customer was advised the pump will need to be replaced.The customer was advised to discontinue use of the pump and was advised to refer to back up plan, per health care professional instructions.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to perform all functional testing including the operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test or verify motor error alarm due to blank display.Motor passed motor test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 8088695
• Report Number: 2032227-2018-63455
• Device Sequence Number: 16495467
• Product Code: OYC
• UDI-Device Identifier: 00613994904508
• UDI-Public: (01)00613994904508
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A000202977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-RSR-UNK, UNK-INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 66