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

Model Number MMT-751NAH

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 08/23/2015

Event Type  malfunction  

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.(b)(4).

Event Description

The customer's mother reported via phone call of a bolus wizard on the insulin pump.The customer's mother stated that the pump was giving the wrong amount of insulin on the pump 2 times.The customer's mother stated that the pump gave the wrong correction and cancelled the deliveries before they occurred.The customer's mother felt the pump will deliver too much insulin causing the customer to have a low blood glucose reading.The customer will be sent a replacement pump.

Manufacturer Narrative

The insulin pump was programmed bolus wizard feature with blood glucose of 140 mg/dl, 70 grams food intake and it's estimated of 2.65 units.The unit was delivered 2.65 units correctly and recorded in bolus history screen.No bolus wizard anomaly noted.The insulin pump had minor scratched lcd window and cracked reservoir tube lip.

• 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5115311
• MDR Text Key: 27223331
• Report Number: 2032227-2015-51300
• 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: other
• Report Date: 09/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Date Manufacturer Received: 09/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 12 YR
• Patient Weight: 32