MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 1.8ML MMT-326A; PUMP, INFUSION

Model Number MMT-326A

Device Problems Failure to Prime (1492); Improper Flow or Infusion (2954)

Patient Problem Hypoglycemia (1912)

Event Date 08/10/2018

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they experienced several low blood glucose events.The customer reported on (b)(6) 2018 and (b)(6) 2018, their blood glucose reading was below 20 mg/dl.The customer required medical intervention by the paramedics on (b)(6) 2018.The customer declined to go to the hospital during this incident.Customer was treated with a glucose solution.The customer's blood glucose was 34 mg/dl at the time of the call.The customer also reported having high blood glucose of 400 mg/dl, which was treated with the insulin pump.The customer would also change their infusion set and reservoir and their blood glucose would lower to 70 mg/dl.It was also reported insulin would squirt during the prime process.Troubleshooting was declined for the insulin pump.The insulin pump will not be returned for analysis.

• Brand Name: RESERVOIR 1.8ML MMT-326A
• Type of Device: PUMP, INFUSION
• 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: 7858052
• MDR Text Key: 119639744
• Report Number: 2032227-2018-24866
• Device Sequence Number: 1
• Product Code: FRN
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2018
• Is the Device Single Use?: Yes
• 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: 77 YR
• Patient Weight: 160