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

Catalog Number 04912551190

Device Problem Non Reproducible Results (4029)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation reviewed the system's alarm trace and noticed frequent "abnormal sample probe movement" alarms.The customer's d-dimer qc results had bad precision and accuracy.The investigation is ongoing.

Event Description

The initial reporter received questionable d-dimer results for one patient tested on a cobas 6000 c (501) module serial number (b)(4).The patient had two samples collected at different times.The patient's cobas 6000 c (501) module d-dimer results were reported outside the laboratory.The customer performed repeat testing on a cobas 6000 c (501) module, a vidas analyzer, and a "fine care" analyzer.The unit of measurement for the d-dimer result on the "fine care" analyzer was requested but not provided.On (b)(6) 2021, the patient's first sample was collected.The patient's initial d-dimer result on the cobas 6000 c (501) module was 7268 ug/ml.On (b)(6) 2021, the patient's repeat result on the cobas 6000 c (501) module was 8670 ug/ml.On (b)(6) 2021, the patient's repeat result on the vidas analyzer was <0.1 mg/l.On (b)(6) 2021, the patient's second sample was collected.The patient's initial d-dimer result on the cobas 6000 c (501) module was 8496 ug/ml.On an unknown date and time, the patient's d-dimer result on the "fine care" analyzer was "less than 150." the patient's d-dimer result on the vidas analyzer was 250 mg/l.

Manufacturer Narrative

The observed differences in d-dimer values generated with the roche assay, vidas assay, and "fine care" assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.Based on the available information, 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
• 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: 12589403
• MDR Text Key: 275231094
• Report Number: 1823260-2021-02932
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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: 03/31/2022
• Device Catalogue Number: 04912551190
• Device Lot Number: 52868701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 11/09/2021
• 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