MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-396T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-396T
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
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
Customer reported via phone call that they experienced high blood glucose level of over 500 mg/dl.Customer's blood glucose level at the time of incident was 519 mg/dl.The customer did not provide the symptoms regarding high blood glucose.Customer stated that the infusion set was bent which caused the high blood glucose.The customer was treated for the high blood glucose with shots and changing infusion set.The customer declined troubleshooting for high blood glucose level.The insulin pump was not returned for analysis.

• Brand Name: PARADIGM QUICK SET MMT-396T
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8951374
• Report Number: 2032227-2019-55739
• Device Sequence Number: 16676553
• Product Code: FPA
• UDI-Device Identifier: 05705244020528
• UDI-Public: (01)05705244020528(17)220601(10)5274393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/01/2022
• Device Model Number: MMT-396T
• Device Catalogue Number: MMT-396T
• Device Lot Number: 5274393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR
• Patient Age: 59 YR
• Patient Weight: 137