MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT D-DIMER; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem High Test Results (2457)

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

Event Date 03/30/2014

Event Type  malfunction  

Event Description

The customer alleged they received a questionable d-dimer result for one patient.The specific date of this event was requested but not provided.The customer tested the patient's sample with the d-dimer assay on a (b)(4) analyzer.The result was 10.61 ug/ml.Information on whether the result was reported outside the laboratory was requested but not provided.The customer suspected the result was falsely high and returned the patient's sample for investigation.The sample was tested with the d-dimer assay on an integra 400 plus analyzer and the result was 8.87 ug/ml.The sample was tested with a hexamate d-dimer assay from medical and biological laboratories co.Ltd on a sta-r evolution analyzer and the result was 1.46 ug/ml.The sample was tested with a sta liatest d-dimer assay on a sta-r evolution analyzer and the result was 1.70 ug/ml.There were no deaths, injuries, illnesses, or deteriorations in health associated with the erroneous results.The customer would not provide information on whether the patient was harmed by this event.

Manufacturer Narrative

This event occurred in (b)(4).

• Brand Name: TINA-QUANT D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3747774
• MDR Text Key: 4469871
• Report Number: 1823260-2014-02620
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04912551190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/30/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1