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

Model Number	MMT-551LNAH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump received with cracked battery tube threads, broken reservoir tube lip, broken belt clip slot, cracked case display window corner, cracked lcd window, cracked case reservoir tube window corner and stained end cap sticker.The p-cap does not locks into the reservoir compartment properly noted.(b)(4).
Event or Problem Description
Information received by medtronic indicated that retainer ring was chipped.No harm requiring medical intervention was reported.The customer was assisted with troubleshooting.Customer stated that reservoir able to lock in place when inserted into insulin pump.The device will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAH
• 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: 10807258
• Report Number: 2032227-2020-202526
• Device Sequence Number: 4177975
• Product Code: OZO
• UDI-Device Identifier: 00643169507708
• UDI-Public: (01)00643169507708
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/08/2020

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-551LNAH
• Device Catalogue Number: MMT-551LNAH
• Device Lot Number: A4551LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 61