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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Results can differ between tests due to different specificity of the antibody used or other test characteristics.D-dimer is not a standardized analyte and results generated using different d-dimer assays are not necessarily identical due to factors such as (but not limited to): reactivity/specificity of different antibodies.Epitope expression during fibrin formation and degradation.Heterogeneity of the fibrin degradation products in plasma.Calibrator material.Variation in optical detection ability between different instruments.Assay formats (latex bead size and required wavelengths).Interference by other analytes (e.G.Rheumatoid factor (rf), mouse monoclonal antibodies.The investigation could not identify a product problem.This event occurred in (b)(6).Udi number = (b)(4).

Event Description

The initial reporter stated they received discrepant results for two samples collected from the same patient and tested with d-di tina-quant d-dimer gen.2 on a cobas 6000 c (501) module.No incorrect results were reported outside of the laboratory.The reporter stated that since the patient was recovering, was stable, and il6 values dropped from a previous value of 9.76 (no units provided) to 2.15, it was expected that d-dimer values would drop as well.The first sample resulted in a d-dimer value of 4006 ng/ml when tested on the c 501 analyzer.The sample was repeated on a vidas analyzer, resulting in a value of 278.39 ng/ml.The second sample resulted in a d-dimer value of 3848 ng/ml when tested on the c 501 analyzer.The sample was repeated on a vidas analyzer, resulting in a value of 284.81.This sample was then diluted 1:5 and repeated on the c 501 analyzer, resulting in a value of 7049 ng/ml on (b)(6) 2021.The sample was also diluted 1:10 and repeated on the c 501 analyzer, resulting in a value of 6904 ng/ml on (b)(6) 2021.The third sample resulted in a d-dimer value of 3709 ng/ml when tested on the c 501 analyzer on (b)(6) 2021.When repeated on a vidas analyzer, this sample resulted in a value of 346.36 ng/ml.The sample was also repeated on a horiba pentra 400 system, resulting in a value of 294 ng/ml.The serial number of the c 501 analyzer is (b)(4).

• Brand Name: D-DIMER
• Type of Device: 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: 11677067
• MDR Text Key: 245756958
• Report Number: 1823260-2021-01156
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2021

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: 11/30/2021
• Device Catalogue Number: 04912551190
• Device Lot Number: 509145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/16/2021
• 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: CROCIN ("SOS ON FEVER").; DOXY TABLET (ONE TAB AFTER BREAKFAST FOR 5 DAYS).; LUPENOX INJECTION.; PAN (BEFORE BREAKFAST FOR 10 DAYS).; REMDESIVIR INJECTION.; VITAMIN C TABLET (ONE AT 8 A.M., ONE AT 8 P.M.).; ZINC TABLET (ONE AT 8 A.M.).