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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable high d-di tina-quant d-dimer gen 2 results for one patient from the cobas 4000 c (311) system.The serial number was requested but was not provided.The initial result was 1080 ng/ml and was reported outside of the laboratory.As this was unexpectedly high, the patient went for retesting in another laboratory.The test was performed on sta compact max instrument and the result was <500 ng/ml (normal).The patient complained to the laboratory and the sample was repeated on the c311 on (b)(6) 2018 with a result of 1080 ng/ml.On (b)(6) 2018, a sample from the patient was repeated on the c311 and the result was 940 ng/ml.A sample from the patient was also tested on a siemens instrument and the result was <150 ng/ml.On (b)(6) 2018, a sample from the patient was repeated on the c311 and the result was 1170 ng/ml.On (b)(6) 2018, a sample from the patient was tested on the c311 with dilutions: with pre-dilution 1:50, the result was 480 ng/ml.With pre-dilution 1:10, the result was 900 ng/ml.With an automatic 1:24 dilution, the result was 1300 ng/ml.No treatment was based upon the high result.The patient stated that he visited an "angiologist" because of the high d-dimer result and that ultrasonic examination results were normal.There was no allegation of an adverse event.

Manufacturer Narrative

A stored (frozen) sample from the patient was tested and the d-dimer result was 1430 ng/ml.It was unclear which sample was used for the testing.The siemens instrument used was a cs 5100.

Manufacturer Narrative

The quality control data is within acceptable range.The calibration data is acceptable.The reaction curve from the sample with result of 1430 ng/ml did not indicate any issues.

Manufacturer Narrative

From the qc and calibration data, a general regent issue can be excluded.With the provided data, it is not clear which result is correct.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7704806
• MDR Text Key: 114715811
• Report Number: 1823260-2018-02405
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2018

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: 04912551190
• Device Lot Number: 278482
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 07/06/2018; 07/06/2018
• Supplement Dates FDA Received: 08/06/2018; 08/30/2018; 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDROL; OMEGA-3; ROCEPHIN; SERETIN
• Patient Age: 49 YR