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 Code	Hyperglycemia (1905)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unit received with completely broken reservoir tube lip.Unable to perform basic occlusion test, displacement tes and occlusion test due to broken reservoir tube lip.However, unit was received passed rewind test, prime/a33 test and excessive no delivery test.Unit had minor scratched lcd window, cracked lcd window, cracked battery tube threads, missing reservoir tube o-ring, cracked case at display window corners, cracked reservoir tube, cracked reservoir tube window, cracked case at reservoir tube window corners, stained address/serial number label and stained end cap sticker.
Event or Problem Description
The customer reported via phone call that pump had crack on the side of the reservoir and experienced high blood glucose level.The customer¿s blood glucose level was 307 mg/dl.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.

• 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: 7368318
• Report Number: 3004209178-2018-59617
• Device Sequence Number: 16282416
• Product Code: OZO
• UDI-Device Identifier: 00643169507265
• UDI-Public: (01)00643169507265
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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-551PNAB
• Device Catalogue Number: MMT-551PNAB
• Device Lot Number: A3551PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 140