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

Model Number MMT-551LNAP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Discomfort (2330)

Event Date 05/05/2020

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.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 Description

The customer reported via phone call that they experienced high blood glucose.The customer¿s blood glucose level was 500 mg/dl which was treated with insulin shot.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer was not comfortable with the insulin pump anymore.Customer was declined to continue insulin pump troubleshooting.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAP
• 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10045991
• MDR Text Key: 190601802
• Report Number: 2032227-2020-116600
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507722
• UDI-Public: (01)00643169507722
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAP
• Device Catalogue Number: MMT-551LNAP
• Device Lot Number: A4551LNAPJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Date Device Manufactured: 09/09/2016
• 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-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 135