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

Model Number	MMT-551PNAB
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/01/2018
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
Customer reported via phone call that customer was hospitalized due to high blood glucose of over 700mg/dl, diabetic ketoacidosis, minor heart attack and kidney failure on (b)(6) 2018.Customer¿s current blood glucose was 215mg/dl.Customer had symptoms like exhaustion, loss of consciousness.Customer was wearing insulin pump at time of hospitalization.Customer alleged for possible under delivery of insulin pump but drive support cap was normal and insulin exited at quick release.Customer also reported that insulin pump keeps alarming and shutting off with new batteries.Customer performed troubleshoot but display did return.Insulin pump will be return for analysis.
Additional Manufacturer Narrative
Unit passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and delivery accuracy test.The stop current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and unexpected restart error test.Unit powered up properly after the test battery was installed.Unit was monitored for three days.No blank display, audio/beep anomaly or displayable history crc check failed alarm noted.However, displayable history crc check failed alarm noted in the alarm history screen due to corrupted history file.

• Brand Name: 530G INSULIN PUMP MMT-551PNAB
• 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: 7555913
• Report Number: 3004209178-2018-75439
• Device Sequence Number: 18900821
• Product Code: OZO
• UDI-Device Identifier: 00643169507265
• UDI-Public: (01)00643169507265
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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-551PNAB
• Device Catalogue Number: MMT-551PNAB
• Device Lot Number: A3551PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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: MMT-326A; MMT-399
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR
• Patient Weight: 120