MAUDE Adverse Event Report: GLUCO RX / TAIDOC TECHNOLOGY CORP. GLUCO RX NEXUS TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Lot Number TD18C219-COE

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  Injury  

Event Description

Glucose testing strips showing error code (used before) as described by pt.Fda safety report id# (b)(4).

• Brand Name: GLUCO RX NEXUS TEST STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): GLUCO RX / TAIDOC TECHNOLOGY CORP.
• MDR Report Key: 8662461
• MDR Text Key: 146946462
• Report Number: MW5087081
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Lot Number: TD18C219-COE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91