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 Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 12/01/2017

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.

Event Description

The customer reported via phone call that their insulin pump is over delivering insulin.The customer¿s blood glucose level was 63 mg/dl at the time of the incident and 210 mg/dl at the time of the call.The customer stated the pump was delivering even after being suspended or after they treat for lows with juice.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test, self test and unexpected restart error test.No bolus anomaly noted during testing.Pump passed all operating currents tested within the specification range and passed off no power test.Pump passed the delivery accuracy test.Pump received with corroded battery tube, cracked battery tube thread, cracked reservoir tube lip, cracked case near display window corners, cracked on display window and minor scratches on display window noted.Drive support cap was inspected and no anomaly was noted.

• 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: 7173941
• MDR Text Key: 96763856
• Report Number: 3004209178-2018-41680
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• 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: 01/08/2018
• Date Manufacturer Received: 04/09/2018
• 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: 73 YR
• Patient Weight: 154