MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump passed the displacement test.Insulin pump received with motor error alarm during the basic occlusion test due to loose, flush drive support disk.Unable to perform prime, compromised force system test, excessive no delivery test and occlusion test due to motor error alarm.Insulin pump received with cracked reservoir tube lip, cracked battery tube threads and stained end cap sticker.The test infusion set and reservoir does lock into place.
Event or Problem Description
Information received by med information received by medtronic indicated that the insulin pump had motor error alarm.Customer had issues where when he puts battery in the pump wont recognize it and he has to change them several times.Customer stated that drive support cap was normal, insulin pump was not exposed to a high magnetic field and declined motor position encoder error alert.Customer was able to clear and able rewind the insulin pump.No harm requiring medical intervention was reported.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB
• 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; * 00777-3869
• MDR Report Key: 11573310
• Report Number: 2032227-2021-128398
• Device Sequence Number: 3021103
• Product Code: OYC
• UDI-Device Identifier: 00643169513877
• UDI-Public: (01)00643169513877
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A5723LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 96