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

Model Number	MMT-523LNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2018
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.The device has been returned, but not yet evaluated.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 the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was 182 at the time of the incident.The customer stated that the drive support cap appears sticking out.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
A test reservoir was installed and did not lock in place due to completely broken reservoir tube lip.Unable to perform rewind test, basic occlusion, occlusion, prime/compromised force sensor system, excessive no delivery and displacement test or verify compromised force sensor system alarm due to completely broken reservoir tube lip.Also, the device had loose/protruded drive support disk and missing reservoir tube o-ring.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL
• 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: 7427487
• Report Number: 2032227-2018-02517
• Device Sequence Number: 19323628
• Product Code: OYC
• UDI-Device Identifier: 00613994748829
• UDI-Public: (01)00613994748829
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/12/2018

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A000168586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 03/25/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 155