MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-751LNAS

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)

Event Date 04/14/2017

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call that they experienced low blood glucose levels of 30 mg/dl.The customer was treated for the low blood glucose with orange juice and cereal.Customer's blood glucose level was 530 mg/dl at the time of the call.The customer was assisted with troubleshooting.Customer stated that the drive support cap was normal.The customer was not connected to the insulin pump while priming the device.There was no indication that the insulin pump over delivered insulin.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.Customer was advised a tubing clamp will be sent to perform the high pressure test.The product was not returned for analysis.

• Brand Name: 530G INSULIN PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6570226
• MDR Text Key: 75264402
• Report Number: 3004209178-2017-73403
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• 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: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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 Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 111