MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; OZO

Model Number MMT-551LNAP

Device Problems Bent (1059); Use of Incorrect Control/Treatment Settings (1126); Kinked (1339)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970); Respiratory Distress (2045); Vomiting (2144)

Event Date 03/28/2017

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

The customer reported via phone call that they were experiencing high blood glucose.The customer changed the infusion set in the morning.By noon the customer's blood glucose level was 119 mg/dl.In the afternoon their blood glucose level was 340 mg/dl.They did a bolus to treat the high blood glucose but later their blood glucose went up to 500 mg/dl.The customer took the insulin pump off and saw that the line was kinked.The customer did another bolus that was up to 10 units but when they checked their blood glucose it was 692 mg/dl.The customer treated the high blood glucose with manual injections.The customer had symptoms of nausea, vomiting, abdominal pain, and difficulty of breathing.Troubleshooting was performed and it was found that they had a bent cannula and that their bolus wizard settings were not correct.The customer was assisted with programming their bolus wizard settings.The customer was advised to continue to monitor their blood glucose.

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• 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: 6528079
• MDR Text Key: 73893968
• Report Number: 3004209178-2017-49312
• Device Sequence Number: 1
• Product Code: OZO
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• 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: 58 YR
• Patient Weight: 111