MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number TRUETRACK

Device Problem Low Test Results (2458)

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

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Consumer complaint of about low blood results.Customer performed blood test with a result of 39 mg/dl.Opened another vial of test strips and tested with a result of 87mg/dl.Based on parkes error grid analysis, the bias between the lowest result (37) and the highest result (87) is located zone b/c.No adverse event reported.

Manufacturer Narrative

Product not yet returned for eval.(b)(4).

• Brand Name: TRUETRACK
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): NIPRO DIAGNOSTICS, INC.; 2400 nw 55th ct; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th ct; fort lauderdale, FL 33309
• MDR Report Key: 3979045
• MDR Text Key: 4632028
• Report Number: 1052693-2014-00155
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RR4337
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1