MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP 630G; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-1755KMK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Cramp(s) (2193)

Event Date 12/18/2016

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

The customer reported via phone call of low blood glucose of 49mg/dl.The customer had symptoms such leg cramps and treated with sugar.Customer indicated that their doctor has been contacted and their blood glucose value was 337 mg/dl at the time of the call.Troubleshooting was performed and found that the site is changed every 2 to 3 days and the drive support cap appeared normal.There were no leaks, air bubbles, site or insulin issues.The device settings were correct.The insulin pump passed the high pressure test.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The product was not returned for analysis.

• Brand Name: PUMP 630G
• 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: 6252467
• MDR Text Key: 64887695
• Report Number: 3004209178-2017-83974
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• 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: 12/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1755KMK
• Device Catalogue Number: MMT-1755KMK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2016
• 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: 66 YR
• Patient Weight: 78