MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
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.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 had motor error and motor position encoder error.The customer¿s blood glucose level was 160 mg/dl.The troubleshooting was performed.Customer reported that the drive support cap appears normal.The customer was advised the insulin pump will need to be replaced and to discontinue use of the insulin pump and recommended customer to refer to back up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received unable to perform all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test or verify motor error alarm due to completely broken reservoir tube lip.Unable to verify motor position encoder in the alarm history due to history file overwritten with displayable history crc check failed on startup alarms.Displayable history crc check failed on startup alarms due to a corrupted history file.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB
• 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: 8372740
• Report Number: 2032227-2019-01753
• Device Sequence Number: 2203480
• Product Code: OYC
• UDI-Device Identifier: 00613994407726
• UDI-Public: (01)00613994407726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/15/2019

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 Model Number: MMT-522LNAB
• Device Catalogue Number: MMT-522LNAB
• Device Lot Number: A000114252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 190