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

Model Number MMT-751LNAL

Device Problems Inaccurate Delivery (2339); Low Test Results (2458)

Patient Problem Hypoglycemia (1912)

Event Date 04/28/2018

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.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

Customer's parent reported via phone call that the customer experienced low blood glucose on (b)(6) 2018 with blood glucose of 42 mg/dl at the time of the incident.The customer started having the lows after playing sports.The customer was at 278 mg/dl at the time of the call.The customer was given food to treat.The customer was wearing the insulin pump during the incident.The caller stated the pump was over delivering as they would eat, take off the pump to play sports, put the pump back on, and then go low.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.

Manufacturer Narrative

The device alarmed motor error during basic occlusion test due to faulty force sensor resistor.Unable to perform rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test or verify possible under or over delivery due to motor error alarm.The device was received with normal operating currents and passed unexpected restart error test and self-test.Motor passed the motor test.

• Brand Name: 530G INSULIN PUMP MMT-751LNAL
• 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: 7547977
• MDR Text Key: 109366068
• Report Number: 3004209178-2018-74545
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169933200
• UDI-Public: (01)00643169933200
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAL
• Device Catalogue Number: MMT-751LNAL
• Device Lot Number: A5751LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Date Manufacturer Received: 06/11/2018
• 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 Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 100