MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAB
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
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.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 reported via phone call that the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was 127 mg/dl at the time of the incident and took manual injection.The customer stated that the drive support cap was normal.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 not be returned for analysis.
Additional Manufacturer Narrative
Device was received with a broken off end cap.Unable to perform the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test, delivery accuracy test, the stop current and run current measurement tests, self test, off no power alarm test and a21 error test due to physical damage on the pump.Unable to test for a33 alarm due to physical damage on the device.Device uploaded properly using carelink.Device also had broken reservoir tube lip, missing reservoir tube o-ring, cracked case at the reservoir tube window corner, cracked reservoir tube window, missing end cap sticker, cracked case at display window corner, broken battery tube threads and customer applying duct tape on the end cap.The test p-cap and reservoir will not lock in place in the reservoir compartment due to broken reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB
• 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: 9363047
• Report Number: 2032227-2019-121642
• Device Sequence Number: 2973578
• Product Code: OYC
• UDI-Device Identifier: 00613994372024
• UDI-Public: (01)00613994372024
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/24/2020

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-522NAB
• Device Catalogue Number: MMT-522NAB
• Device Lot Number: A4522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 82