MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-975T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/28/2019
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
A customer reported via phone call indicating that they had an occlusion with their infusion set.The customer¿s blood glucose level was 464 mg/dl at the time of the incident.The customer stated that they tried multiple sets but had all failed.The customer states that the infusion sets are not lasting the full time frame in which they should last.The customer reverted to their back up plan but did not state how they treated their high blood glucose levels.The customer did not troubleshoot but did send the product back for analysis.

• Brand Name: INFST MM T-975T MIO 2PK 9MM 32IN CLEAR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8675209
• Report Number: 2032227-2019-12586
• Device Sequence Number: 3020671
• Product Code: FPA
• UDI-Device Identifier: 05705244020580
• UDI-Public: (01)05705244020580(17)220101(10)5263421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/06/2019

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 Model Number: MMT-975T
• Device Catalogue Number: MMT-975T
• Device Lot Number: 5263421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/06/2019
• 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: RESVR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 93