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 Codes	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit passed displacement, sleep current measurement, active current measurement tests; it failed self test.No unexpected blank displays or unexpected "insert battery", ¿low battery¿, ¿replace battery¿, ¿replace battery now¿, or "power loss" errors were noted during testing.Self test returned a pump error 75.After further review of the unit¿s interior, did not note any evidence of previous moisture presence or corrosion on any of the electronic boards or assemblies.The pump error 75 is due to a problem associated with the electronic assembly.Pump trace download analysis confirmed the unit alarmed pump error 25.The power management tool confirmed pump error 25 was triggered when the backup battery loaded voltage (loaded vlith) was less than 3.5v for 4 consecutive hours due to connector resistance j6 /pcb 1.After disconnecting and reconnecting the internal battery connector on j6/pcb 1, the unit was monitored and functioned properly.(b)(4).
Event or Problem Description
Information received by medtronic indicated that battery did not last more than 1 week.Customer stated that the insulin pump had power loss alarm.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• 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; * 00777-3869
• MDR Report Key: 9635746
• Report Number: 3004209178-2020-60777
• Device Sequence Number: 2908288
• Product Code: OZO
• UDI-Device Identifier: 00643169752726
• UDI-Public: (01)00643169752726(017)20170611
• Combination Product (Y/N): N
• 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): 01/28/2020

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 Expiration Date: 06/11/2017
• Device Model Number: MMT-1755K
• Device Catalogue Number: MMT-1755K
• Device Lot Number: HG1J8ZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR