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 04/23/2015

Event Type  malfunction  

Event Description

The customer received a low questionable cardiac d-dimer result for one patient sample on cobas h232 serial number (b)(4).The h232 meter is not sold in the united states.On (b)(6) 2015, the patient was tested on the cobas h232 and the result was 0.21 ug/ml.When tested with a different sample taken at same time on an il acl top analyzer (reagent il hemosil d dimer high sensitivity latex immunoassay type reagent), the result was 592 ng/ml.The result from the cobas h232 was reported outside the laboratory.The patient was not adversely affected.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Additional information was received that the date received by manufacturer was actually (b)(6) 2015.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.As the strip lot number was not provided and strips were not sent in, no retention testing or further investigation was possible.The cobas h232 meter was submitted for investigation.No test results were present in the memory of the meter for the date of the event nor was any result of 0.21 ng/ml found.

• 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; SZ 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4752909
• MDR Text Key: 5827618
• Report Number: 1823260-2015-03421
• 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
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/23/2015
• 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: 038 YR
• Patient Weight: 105