MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR 3ML; PUMP, INFUSION

Model Number MMT-XXX

Device Problems Break (1069); Crack (1135); Failure to Prime (1492); Component Missing (2306)

Patient Problem Hypoglycemia (1912)

Event Date 05/24/2018

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 reported via phone call that they experienced low blood glucose and insulin pump had prime rewind anomaly.Customer¿s blood glucose at the time of the incident was 48 mg/dl and current blood glucose was 184 mg/dl.The customer reported that insulin was squirting out during the manual prime process and there was a lot of cracks and missing pieces on the rim of reservoir compartment.Troubleshooting was performed for rewind anomaly and damage.Troubleshooting was declined for low blood glucose.The drive support cap was appeared normal.The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose.The insulin pump will be returned for analysis.

• Brand Name: RESERVOIR 3ML
• 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: 7632012
• MDR Text Key: 112136084
• Report Number: 2032227-2018-07133
• 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: Patient
• 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): Other
• Patient Age: 37 YR
• Patient Weight: 165