MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAH

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fall (1848); Concussion (2192)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

The customer reported via phone call that the customer fell on concrete due to concussion and hospitalized due on (b)(6) 2017 and blood glucose was unknown.The customer treated their high blood glucose with intravenous drip.The customer was wearing insulin pump during hospitalization.The customer reported that the insulin was squirting out during manual prime.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with operating currents within spec.Device passed self test, unexpected restart error test, rewind, basic occlusion test, occlusion test, prime or compromised force sensor system alarm test, excessive no delivery test, displacement test.Device passed delivery accuracy test.No prime fill anomalies noted.Device received with cracked reservoir tube lip, cracked case at display window corners, broken battery tube threads and minor scratches on lcd window.

• Brand Name: 530G INSULIN PUMP MMT-751NAH
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7088182
• MDR Text Key: 94140573
• Report Number: 2032227-2017-70604
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503687
• UDI-Public: (01)00643169503687
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• 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
• Device Lot Number: A4751NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Date Manufacturer Received: 05/15/2018
• 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 Age: 57 YR
• Patient Weight: 75