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 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

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.A sample from the patient was tested for ddi on the cobas h 232 analyzer, resulting as 0.71 ug/ml and this value was reported outside of the laboratory.The patient had a second sample collected approximately 1 hour later and this was tested in an external laboratory on an acl top instrument, resulting as 1187.0 ug/l.The patient was not adversely affected.The cobas h 232 analyzer serial number is (b)(4).It was stated that the customer ran an internal control on the cobas h 232 analyzer prior to sample testing and one control level failed.

Manufacturer Narrative

The customer provided the test strips and cobas h 232 analyzer for investigation.Temperature requirements for the test strips were not met and kept during the transport of this material.Both retention and customer materials were investigated.All investigation measurements fulfilled requirements.The investigated material can be ruled out as a failure source.It was noted that the customer used tubes which have not been evaluated for use with the test.Interferences present in the sample or an issue with processing of the test could not be ruled out as possible causes.

• 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: 5697420
• MDR Text Key: 46494561
• Report Number: 1823260-2016-00715
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/22/2016

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: 01/31/2017
• Device Catalogue Number: 04877802190
• Device Lot Number: 119616-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/07/2016; 06/22/2016
• 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