MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML

Model Number MMT-332A

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 01/29/2017

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 reported via phone call that they experienced high blood glucose level of 521 mg/dl.The customer treated with 20 units of injection.Troubleshooting was performed.The insulin pump alarmed no delivery.Customer was assisted with performing 5.0 unit fixed prime.The customer stated that the pump alarmed no delivery with manual prime.The product was returned for analysis.

• Brand Name: RESERVOIR 3ML
• Type of Device: RESERVOIR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6346939
• MDR Text Key: 67875277
• Report Number: 3004209178-2017-91694
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K032005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR