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 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).

Event Description

The customer stated that they received an erroneous result 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.There was no report of any error messages occurring on the analyzer.The date that the event occurred was asked for, but not provided.A sample from the patient was tested for ddi on the cobas h 232 analyzer, resulting as 3.90 ug/ml.It was asked, but it is not known if the value was reported outside of the laboratory.A different sample tube collected at the same time was tested using a different test method at a clinical commercial laboratory and this sample resulted as 63.2 ug/ml.It was asked, but it could not be confirmed by the customer which value was considered to be correct.The patient was not adversely affected.The cobas h 232 analyzer serial number was (b)(4).It was explained to the customer that results using different methods can differ because calculation and cut-off values are different.It was also explained to the customer that since the result using the different test method indicates a high concentration of d-dimer, a hook effect may be the root cause of the discrepancy.

Manufacturer Narrative

The customer analyzer and test strips were requested for investigation, but could not be provided.Retention materials were tested and all test results were within accordance of the testing plan.The customer agreed with the explanation that results using different methods can differ and based on the results provided, a hook effect may be the root cause of the discrepancy.

• 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: 5906029
• MDR Text Key: 53295084
• Report Number: 1823260-2016-01279
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

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 Expiration Date: 11/30/2016
• Device Catalogue Number: 04877802190
• Device Lot Number: 28245810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• 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