MAUDE Adverse Event Report: MEDTRONIC MINIMED 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 Codes	Premature Discharge of Battery (1057); Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that the insulin pump had unexpected restart and screen was hard to read.The customer¿s blood glucose level was unknown at the time of the incident.Customer reported that the insulin pump reject new batteries grinding while rewinding and the insulin pump lost date and time setting.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with severe scratches on lcd display window noted.Insulin pump passed displacement test, self test, a21 error test, off no power test and all operating currents tested within the spec range.No unexpected low battery alarm, rewind anomaly or missing segments were noted.

• 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 MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8398228
• Report Number: 2032227-2019-02029
• Device Sequence Number: 390147
• Product Code: OYC
• UDI-Device Identifier: 00885074419800
• UDI-Public: (01)00885074419800(17)091231
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/31/2019

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 Expiration Date: 12/31/2009
• Device Model Number: MMT-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A1722NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 150