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 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of high results for 1 patient tested for d-di2 tina-quant d-dimer gen.2 (d-di2) on a cobas integra 400 plus.On (b)(6) 2018 the patient was initially tested on the integra 400 plus instrument with a result of 1423 ng/ml.A new sample was obtained on (b)(6) 2018 and the result from the integra 400 plus was 1440 ng/ml.The patient was tested 1 week prior to the event on a coagulogic analyzer and the d-dimer result was < 500 ng/ml.The result of < 500 ng/ml better corresponds to the patient's clinical condition.On (b)(6) 2018 the sample from (b)(6) 2018 was tested on an acl analyzer top 500 instrument and the result was 367 ng/ml.This same sample was also run in another laboratory using an acl analyzer top 300 instrument and the result was 194 ng/ml.The result of 1440 ng/ml was reported outside of the laboratory.There was no allegation that an adverse event occurred.The integra 400 plus serial number was (b)(4).The field service engineer (fse) visited the customer site on 28-jun-2018 to perform regular preventive maintenance and no technical problems were found.

Manufacturer Narrative

The patient had no clinical symptoms and received no treatment.After the patient's first high d-dimer result in 2013, a doppler ultrasound was done and cancer was excluded as a factor for the high results.No specific test details were provided.

Manufacturer Narrative

The patient (who happens to be a doctor) has tested her d-di2 on the integra 400 plus instrument in the past and the results were higher than expected.Refer to attached data for additional relevant test data and the past high d-di2 results.

Manufacturer Narrative

Two samples from the patient were submitted for investigation.The samples were tested on an integra 400 plus instrument, a t511 instrument and a c502 module.The samples were tested with no dilution factor and with a dilution factor.The customer's d-di2 results were partly confirmed.The results from the integra 400 plus used at the investigation site were similar to the customer's results.The results from the diluted samples were approximately 36% lower than the undiluted results.The d-dimer results from the t511 instrument and the c501 module were approximately 55% lower than the results from the integra 400 plus instrument.All d-dimer results were above the cutoff of 0.5 ug/ml.Based on the difference in results between the integra 400 plus and the results from the t511 and c501 instruments, there are immunoglobulins in the patient sample causing a non-specific agglutination leading to the higher results.This interference is addressed in product labeling.Based on the calibration and qc data, a general reagent issue can be excluded.The device did not malfunction.A product problem was not found.

• 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: 7685046
• MDR Text Key: 114154108
• Report Number: 1823260-2018-02308
• 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: 09/04/2018

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 Expiration Date: 05/31/2019
• Device Catalogue Number: 04912551190
• Device Lot Number: 32475701
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 06/28/2018; 06/28/2018
• Supplement Dates FDA Received: 07/24/2018; 08/13/2018; 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LETROX; METFORMIN
• Patient Age: 62 YR