MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAB
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
It was reported that the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was unknown at the time of the incident.The customer stated that the drive support cap was flush.The insulin pump was not dropped or bumped.The customer was advised that to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test.However, device alarmed motor error during basic occlusion test due to loose and protruded drive support disk.Unable to perform occlusion test, prime or a33 test, excessive no delivery test.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9542202
• Report Number: 3004209178-2020-50133
• Device Sequence Number: 19427026
• Product Code: OYC
• UDI-Device Identifier: 00613994622594
• UDI-Public: (01)00613994622594
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A9722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1