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

Model Number MMT-751LNAH

Device Problems No Device Output (1435); Use of Device Problem (1670); Programming Issue (3014)

Patient Problems Hyperglycemia (1905); Tingling (2171)

Event Date 05/17/2016

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 she needed to change out the battery again and the infusion set as well.Customer needed assistance with the setting the basal.Customer's blood glucose was 347 mg/dl - 367 mg/dl.Customer stated that she has currently taken steroids so her blood glucose has been running a little higher than normal.Customer's current blood glucose was 447 mg/dl.Customer reported having tingly arms as symptoms and has syringes and insulin as a back-up plan.Customer stated that she had a steroid injection for her neck for the past 4 months.Customer had an empty reservoir and was not receiving her basal or bolus delivery as normal.Customer was advised to do a complete set change.Customer stated that she has not delivered any bolus since she woke up this morning.Customer stated that she is delivering (b)(4) units of a bolus right now but will need to deliver another 4.7 units to bring her blood glucose down to normal.Customer was advised that a tubing clamp will.

• 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: 5706924
• MDR Text Key: 46824794
• Report Number: 3004209178-2016-52445
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: P120010
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• 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: 51 YR