MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER GEN 2; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2014

Event Type  malfunction  

Event Description

The customer received questionable d-dimer results for one patient from an integra 400 analyzer serial number (b)(4).The initial result from the primary tube was 34.86 ug/ml.The sample was repeated and the result was 28.29 ug/ml.The sample was manually diluted 1:11 and the result was 1.91 ug/ml.On (b)(6) 2014, the sample in the primary tube was retested and the result was 34.46 ug/ml with a data flag.The sample was repeated and the results were 28.47 ug/ml and 5.91 ug/ml.The sample was manually diluted 1:3 and the result was 7.99 ug/ml with a data flag.The sample was repeated and the result was 9.50 ug/ml.Diluted 1:6, the result was 4.99 ug/ml with a data flag.The result of 34.86 ug/ml was reported to the physician.Based on the results, the patient was sent to another hospital and d- dimer was measured on a siemens bcs xp instrument and the result was low positive (around 0.7 mg/l feu).Specific data was not available.The original sample was then tested on an architect analyzer and the result was 745.2 ng/ml.On (b)(6) 2014, the sample was tested on a siemens bcs xp analyzer and the result was 0.747 mg/l.The physician believed the result of 0.747 mg/l to be correct.The patient was sent home, with a note to contact the hospital in case of health deterioration.There was no change in the therapy and the patient was not adversely affected.

Manufacturer Narrative

This event occurred in (b)(6).While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Manufacturer Narrative

Sample from the patient was submitted for investigation and the preliminary findings indicated gammopathy interference.This interference is documented in product labeling.

Manufacturer Narrative

Additional testing confirmed the presence of the gammopathy in the sample which caused the difference in the results.

• Brand Name: D-DIMER GEN 2
• Type of Device: 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: 4413487
• MDR Text Key: 5167037
• Report Number: 1823260-2015-00269
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SR
• PMA/PMN Number: K062203
• 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: 03/16/2015

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: 09/29/2015
• Device Catalogue Number: 04912551190
• Device Lot Number: 602504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2015; 03/16/2015
• 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
• Treatment: FROMILID; BERODUAL SOL; BISOLVON
• Patient Age: 048 YR