MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 10 TESTS (COBAS); 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 03/10/2014

Event Type  malfunction  

Manufacturer Narrative

The customer returned the h232 meter and five unused cardiac d-dimer test strips that were involved in this event for investigation.It was noted the temperature requirements for transport were not met.The returned test strip and retention strips were tested on the returned h232 meter and a qualified meter fulfilled all the requirements.

Event Description

The customer alleged they received a questionable cardiac d-dimer result for one patient on a cobas h232 analyzer, serial number not provided.The cobas h232 is not sold in the united states.The customer stated no hemolysis, icterus, and lipemia appeared in the sample.The patient's d-dimer result was 0.11 ug/ml and it was reported outside the laboratory.The sample was not repeated.On (b)(6) 2014, the physician complained to the laboratory that the d- dimer result did not correspond to the patient's diagnosis of an embolism and thrombosis of other specified veins.The patient received an ultrasound examination that showed subacute thrombosis (intraluminal echogenic thrombus) of the bilateral common femoral veins, superficial formal veins, right popliteal vein, and right peroneal vein.All the mentioned venous thrombosis showed "no compressible." the patient was not adversely affected by this event.Retention d-dimer tests strips from lot 28166610 were tested on a qualified h232 device for investigation.The results of all the measurements fulfilled the requirements.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: ROCHE CARDIAC D-DIMER 10 TESTS (COBAS)
• Type of Device: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS
• 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: 3723875
• MDR Text Key: 11766099
• Report Number: 1823260-2014-02342
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 04877802190
• Device Lot Number: 28166610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 03/20/2014
• 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
• Treatment: WARFARIN
• Patient Age: 047 YR