MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551LNAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551LNAB
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The insulin pump was received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to perform all functional testing including the operating currents, unexpected error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test or verify absence of occlusion alarm due to blank display.
Event or Problem Description
The customer reported via phone call that they had insulin delivery issue and insulin pump did not notify with no delivery alert.The customer¿s blood glucose level was unknown at the time of incident.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAB
• 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: 9427866
• Report Number: 2032227-2019-128741
• Device Sequence Number: 2403011
• Product Code: OZO
• UDI-Device Identifier: 00643169507692
• UDI-Public: (01)00643169507692
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/06/2019

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-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A4551LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2018
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 182