MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number MMT-XXX

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

Patient Problem Hyperglycemia (1905)

Event Date 04/30/2018

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

Event Description

The customer's spouse reported via phone call that the customer was hospitalized due to high blood glucose on (b)(6) 2018 and (b)(6) 2018 with blood glucose of 500 mg/dl.Customer's spouse reported that the customer's blood glucose was running high in the 300 mg/dl to 600 mg/dl.The customer was treated with manual injection.Customer's blood glucose reading was 380 mg/dl at the time of call.The customer was wearing the insulin pump during the hospitalization.Customer also reported that the insulin pump had a motor error alarm and they were unable to completed the rewind process.The customer's spouse was advised to have customer discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.Pump was unable to prime unit during prime/a33 test due to faulty fsr (gold).The pump was received with intermittent up arrow button due to flattened dome switches (no crease).

• Brand Name: RESERVOIR 3ML MMT-332A
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7631836
• MDR Text Key: 112140008
• Report Number: 2032227-2018-07079
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2018
• 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): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 211