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

Model Number MMT-751NAL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problems Stroke/CVA (1770); Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)

Event Date 09/01/2016

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 that he was in the hospital for a stroke.Customer stated that the hospital took the insulin pump off him and his blood glucose would range from 30-440 mg/dl.Customer was off the pump from (b)(6) 2016.Customer stated that he had the sensor running at the hospital to be safe.Customer had been off the pump for 1-2 weeks prior to the low blood glucose level.Customer stated that the hospital was giving him lots of insulin even when he didn't need it.Customer had two incidents when he woke up with a blood glucose level of 30 mg/dl when he was off the pump.Customer's blood glucose dropped down to 38-40 mg/dl one time when he went back on the pump on (b)(6) 2016.Customer used glucagon to treat.Customer reported issues with differences in sensor readings and blood glucose readings.Troubleshooting was performed for the calibration error issues.Customer declined troubleshooting for the low 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: 6226817
• MDR Text Key: 64018092
• Report Number: 3004209178-2017-80303
• 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: Other
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• 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: 57 YR
• Patient Weight: 94