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

Model Number	MMT-723RNAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
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 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 was reported via phone call that, the customer received with multiple insulin pump errors.The blood glucose was 243 mg/dl at the time of the incident.Alarm did not occur during the rewind and prime sequence.Assisted customer in performing a self test which was failed.Error table indicates the pump should be replaced.The insulin pump was cracked.Troubleshooting determined that, the insulin pump should be replaced and revert to a back-up plan.The insulin device will be returned for analysis.
Additional Manufacturer Narrative
Rf pic failed self test alarm and high stop current due to faulty connector radio frequency board.Device passed the unexpected restart error test, displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.Device received with broken battery tube threads and cracked case at display window corners.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 7239515
• Report Number: 2032227-2018-01251
• Device Sequence Number: 19128868
• Product Code: OYC
• UDI-Device Identifier: 00613994904393
• UDI-Public: (01)00613994904393
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/15/2018

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000204715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 220