MAUDE Adverse Event Report: MEDTRONIC MINIMED STARTER KIT MMT-7730 TRANSMITTER GST3; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7730

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Hypoglycemia (1912)

Event Date 01/29/2019

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

It was reported that they experienced low blood glucose level.The customer¿s blood glucose was 46 mg/dl.The device will be returned for analysis.

• Brand Name: STARTER KIT MMT-7730 TRANSMITTER GST3
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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 ; 8185464805
• MDR Report Key: 8377379
• MDR Text Key: 137366777
• Report Number: 2032227-2019-01821
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00763000009748
• UDI-Public: (01)00763000009748
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7730
• Device Catalogue Number: MMT-7730
• Device Lot Number: W000493525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2018
• 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
• Treatment: FRN-UNK-RSVR, UNOMED SET.
• Patient Outcome(s): Other