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

Model Number	MMT-523RNAB
Medical Device Problem Codes	No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
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
Customer reported via phone call that the insulin pump had blank display.The customer¿s blood glucose level was 198 mg/dl.Customer stated that the contact on the battery cap was neither missing nor damage.Customer stated battery compartment was neither damaged nor corroded.Customer stated that the spring was neither damaged nor corroded.Customer stated that the display did not return after insulin pump restart.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
Device power up properly after battery installation.No blank display noted.Device was received with normal operating currents and passed self-test, a21 error test and displacement test.No unexpected off no power, bad battery , low battery, weak battery, battery out limit or failed battery test alarms noted during testing.Device had cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB
• 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: 9189911
• Report Number: 2032227-2019-103365
• Device Sequence Number: 11680413
• Product Code: OYC
• UDI-Device Identifier: 00643169221512
• UDI-Public: (01)00643169221512
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAB
• Device Catalogue Number: MMT-523RNAB
• Device Lot Number: A000207242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 61