MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER; ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID

Catalog Number 04877802190

Device Problem Low Test Results (2458)

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

Event Date 05/21/2015

Event Type  malfunction  

Manufacturer Narrative

A specific root cause could not be identified.The customer returned the h232 meter.The meter was tested with relevant retention material and the results fulfilled requirements.

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received a questionable cardiac d-dimer result for one patient sample from cobas h232 meter serial number (b)(4).The cobas h232 meter is not sold in the united states.A sample was taken at 11:14 and tested on the cobas h232 meter and the result was 210 ng/ml.At 13:41 a sample was taken and tested in the laboratory on a stago liatest and the result was 970 ng/ml.Information concerning if any erroneous result was reported outside the lab was requested, but was not provided.The patient was hospitalized, but a scan and further investigation pointed to no dvt.The customer did not have official information, but they had heard that results of further investigations for the patient were negative.No adverse event was reported.The investigation tested retention material and the results fulfilled the requirements.

Manufacturer Narrative

Date received by manufacturer" was actually 05/22/2015.Both the result from the h232 meter and the laboratory result were reported to the physician.The negative result meant the patient was not investigated when she should have had "further urgent investigations".The patient was not adversely affected.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID
• 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: 4843743
• MDR Text Key: 21591684
• Report Number: 1823260-2015-03619
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033491
• 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,Followup,Followup,Followup
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04877802190
• Device Lot Number: DD0151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 05/21/2015
• 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
• Treatment: SULFASALAZINE
• Patient Age: 036 YR
• Patient Weight: 60