MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number	MMT-332A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 they were experiencing high blood glucose level.Blood glucose level at the time of the incident was 510 mg/dl.Customer stated reservoir had leak.Customer was performed self test and displacement teat and insulin pump had hardware low level failure alarm.Customer stated they were able to clear the alarm and they were able to rewind insulin pump.It was unknown that customer was using auto mode or not.Customer declined troubleshooting for high blood glucose level.The insulin pump will be returned for analysis and reservoir will not be returned for analysis.

• Brand Name: RESERVOIR 3ML MMT-332A
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 10355805
• Report Number: 2032227-2020-156733
• Device Sequence Number: 11362419
• Product Code: FRN
• UDI-Device Identifier: 20763000273358
• UDI-Public: (01)20763000273358(17)230505(10)HG4ADE1
• 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): 08/03/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/05/2023
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG4ADE1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/03/2020
• 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: UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Weight: 88