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

Model Number MMT-551NAS

Device Problems Failure to Cycle (1142); Detachment of Device or Device Component (2907); Priming Problem (4040)

Patient Problem Hyperglycemia (1905)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they experienced high blood glucose.The customer¿s blood glucose level was over 400 mg/dl at the time of incident.Customer treated high blood glucose with manual injection.Customer stated that the insulin was squirting out instead of dripping.Customer stated that the drive support cap appears normal slightly intended.No further patient complications were reported.Troubleshooting was performed; however, the customer will continue use of the device.

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 14433576
• MDR Text Key: 292036271
• Report Number: 2032227-2022-192055
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169503663
• UDI-Public: (01)000000643169503663
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A4551NASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2022
• Date Device Manufactured: 03/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-326-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 49 KG