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

Model Number	MMT-522LNAS
Medical Device Problem Codes	Device Alarm System (1012); Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The customer reported via phone call that the insulin pump failed to give no delivery alarm while there was no insulin in reservoir.Customer¿s blood glucose level was unknown.Insulin pump had rejected new battery alarm.It was unknown that the insulin pump will be returned or not for analysis.
Additional Manufacturer Narrative
Device passed displacement test, rewind test, basic occlusion test, prime/a33 test, excessive no delivery test and occlusion test, off no power test, self test and all operating currents test.No failed battery test alarm were noted.No delivery anomaly noted during testing.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAS
• 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: 9137938
• Report Number: 2032227-2019-70942
• Device Sequence Number: 3137279
• Product Code: OYC
• UDI-Device Identifier: 00613994407696
• UDI-Public: (01)00613994407696
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/23/2020

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-522LNAS
• Device Catalogue Number: MMT-522LNAS
• Device Lot Number: A1522LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 160