MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER; FIBRINOGEN AND FIBRIN SPLIT PRODUCTS

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer.The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The sample initially resulted as 0.51 ug/ml when tested for ddi on the cobas h 232 analyzer.A second sample collected from the patient at the same time was tested on a laboratory analyzer, resulting as 2.41 ug/ml.Both samples were repeated, with the first sample resulting with a repeat value of 0.53 ug/ml on the cobas h232 analyzer.The second sample was repeated on the laboratory instrument, resulting as 2.24 ug/ml.The patient was not adversely affected.The serial number of the used cobas h 232 analyzer was asked for, but not provided.The customer's cobas h 232 analyzer and ddi test strips have been requested for investigation.

Manufacturer Narrative

It was stated that the used laboratory method was the stago liatest d-di plus method, which is an immune-turbidimetric assay.

Manufacturer Narrative

Retention test strip and a retention cobas h 232 analyzer were tested and all test results fulfilled requirements.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5750949
• MDR Text Key: 48309057
• Report Number: 1823260-2016-00817
• 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,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2016

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: 04877802190
• Device Lot Number: DD5571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/06/2016; 07/19/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1