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

Model Number MMT-751NAL

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.(b)(4).

Event Description

Customer reported via phone call to have received an "off no power" alert and did not receive a low battery alert prior.It was reported that battery had to be changed excessively.Customer also reported that shirt smelled of insulin but did not see insulin leak anywhere and pump was dry.Customer reported that on (b)(6), blood glucose was not under control and blood glucose was 447 mg/dl.Customer reported another occurence of off no power without a low battery warning.Customer was advised that insulin pump would need to be replaced.

Manufacturer Narrative

The pump gave a motor error alarm during the occlusion test due to a faulty force sensor resistor.The pump passed the idle current, run current, self test, off no power, unexpected restart, basic occlusion, displacement and rewind tests.Unable to perform the prime or excessive no delivery tests due to the motor error alarm.No unexpected failed battery test, off no power, low battery, bad battery or blank display noted.No moisture damage on the electronics or motor was noted.The pump was received with minor scratches on the display window, cracked battery tube threads and a 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: 6216463
• MDR Text Key: 63670108
• Report Number: 2032227-2016-55895
• 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,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• 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 Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 66