MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551NAH

Device Problems Device Difficult to Program or Calibrate (1496); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Date 01/04/2020

Event Type  Injury  

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 they experienced high blood glucose and buttons were hard to press.The customer¿s blood glucose level was over 600 mg/dl at the time of incident.The customer¿s heart rate was increased.The customer treated high blood glucose with insulin pump.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer did not allege the insulin pump was under delivering.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.The drive support cap appeared normal.The customer also stated that the buttons did not respond immediately, had to press them several time.The time clock was advancing.The customer reported crack on reservoir compartment and half of the top of the reservoir compartment broke off.The customer also stated that the reservoir lip ring was damaged.Troubleshooting was performed for damage and noticed the reservoir did lock in place.The customer was advised that the pump will need to be replaced and was advised to discontinue use of the pump and revert to a back-up plan.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• 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 ; 8185464805
• MDR Report Key: 9574785
• MDR Text Key: 174517600
• Report Number: 3004209178-2020-54081
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503632
• UDI-Public: (01)00643169503632
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A4551NAHJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Date Device Manufactured: 11/04/2014
• 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
• Treatment: FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 58