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

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

The customer received a questionable cardiac d-dimer result for one patient sample from cobas c232 meter serial number (b)(4).The h232 meter is not sold in the united states.The initial result was 0.78 ug/ml.The result in a lab within 30 minutes was 268 ug/ml.The wells score was -2 and the scan was negative.It was unclear if this result was from the same patient sample.Information concerning which result was reported outside the laboratory was requested, but was not provided.The patient was not adversely affected.His current condition was good and he was discharged.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be determined as no customer strips were submitted for investigation.Relevant retention material was tested and all results fulfilled the requirements.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
• 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: 4809201
• MDR Text Key: 5892743
• Report Number: 1823260-2015-03567
• 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
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• 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: 28217110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 05/15/2015
• 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
• Patient Age: 055 YR
• Patient Weight: 94