MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DI2; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem High Test Results (2457)

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

Event Date 04/05/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with d-di tina-quant d-dimer gen.2 on 2 cobas 6000 c (501) modules.An incorrect result from the sample was reported outside of the laboratory to the patient.The patient's d-dimer was measured because the patient had abdominal pain and the measured results did not match with the patient's symptoms.A high result was not expected.The sample initially resulted in a d-dimer value of 8045 ng/ml when tested on the first c 501 analyzer (serial number (b)(4)).The sample was repeated on the first c501 analyzer, resulting in a value of 8412 ng/ml.The sample was sent to a second laboratory for testing on a second c501 analyzer (serial number unknown), where it resulted in a d-dimer value of 8025 ng/ml.The sample was repeated on the first c501 analyzer on (b)(6) 2022, resulting in a d-dimer value of 8790 ng/ml.The sample was repeated on the first c501 analyzer on (b)(6) 2022 using decreased sample volume, resulting in a value of 9935 ng/ml.The sample was diluted 1:10 and repeated on the first c501 analyzer on (b)(6) 2022, resulting in a value of 4867 ng/ml.The sample was also diluted 1:20 and repeated on the first c501 analyzer on (b)(6) 2022, resulting in a value of 4283 ng/ml.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.No sample was available for investigation.The issue is consistent with the presence of an interfering factor in the sample which interferes with a component of the d-dimer assay.

• Brand Name: D-DI2
• 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: 14165812
• MDR Text Key: 289724824
• Report Number: 1823260-2022-01124
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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: 58095201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• 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
• Patient Age: 4 YR
• Patient Sex: Female