MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755K PUMP 630G 3ML BK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1755K
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
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
It was reported that the insulin pump had an audio anomaly.The device was not making any sound when alarming.They did not hear beeps when the audio volume settings were saved.The device did not pass troubleshooting.The customer¿s blood glucose during the incident was 199 mg/dl and 130 mg/dl.The device will not be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test and self test.Toggled on/off and increased/decreased volume with the audio feature functioning properly.No audio/vibrate/absence of alarm anomalies noted during testing.Device received with pillowing keypad overlay, scratched/peeling keypad overlay texture, scratched display window cover, peeling end cap address serial number label and scratched case.(b)(4).

• Brand Name: KIT MMT-1755K PUMP 630G 3ML BK MG
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 8423427
• Report Number: 3004209178-2019-67941
• Device Sequence Number: 2327035
• Product Code: OZO
• UDI-Device Identifier: 00763000101527
• UDI-Public: (01)00763000101527
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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-1755K
• Device Catalogue Number: MMT-1755K
• Device Lot Number: HG2FK8D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1