MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751LNAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAP

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

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 the insulin pump had display anomaly.The customer¿s blood glucose level was 88mg/dl at the time of the incident.The customer reported that earlier in the day, she pulled her pump out to bolus.Portion of the screen was a darker color than the rest of the screen.Based on troubleshooting the customer was advised to disconnect use of pump.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAP
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7155922
• MDR Text Key: 96117264
• Report Number: 2032227-2017-78567
• Device Sequence Number: 1
• Product Code: OZO
• 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: Patient
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAP
• Device Catalogue Number: MMT-751LNAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 33 YR
• Patient Weight: 222