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	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pump passed the displacement test but motor error alarm during the basic occlusion test due to protruded drive support disk.Unable to perform the occlusion, prime and excessive no delivery test due to motor error alarm.Motor passed motor test.
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level was 400 mg/dl at the time of incident and other blood glucose value was 153 mg/dl.Customer reported that they received motor error alarm.Customer reported the drive support cap was normal.Customer did not received motor position encoder alarm.Customer stated the insulin pump was not exposed to a high magnetic field.Customer was able to complete rewind the insulin pump.The insulin pump will 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; * 00777-3869
• MDR Report Key: 10062474
• Report Number: 2032227-2020-118601
• Device Sequence Number: 17030257
• Product Code: OZO
• UDI-Device Identifier: 00643169507692
• UDI-Public: (01)00643169507692
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 05/15/2020

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-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A4551LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 05/15/2020
• 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: FRN-UNK-RSVR, UNOMED SET
• Patient Age: 15 YR
• Patient Weight: 153