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 09/30/2021

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant high results for 2 patient samples tested for d-dimer on a cobas 6000 c (501) module.Patient 1 initial result from the c501 module was 7.52 ug/ml.This result was reported outside of the laboratory.The repeat result from the c501 module was 7.38 ug/ml.On (b)(6) 2021 the sample was repeated again on the c501 module with results of 7.64 ug/ml, 7.63 ug/ml and 7.69 ug/ml.The sample was then diluted and run on the c501 module: 1:3 result was 0.55 ug/ml, 1:50 result was 0.58 ug/ml with a data flag, 1:20 result was 0.00 ug/ml with a data flag.Patient 1 was transferred to another hospital as the doctor thought she had a deep vein thrombosis.The d-dimer result from a bcs coagulation analyzer was 0.3 ug feu/ml.The customer was informed of the 0.3 ug feu/ml result.On (b)(6) 2021 the customer sent the patient sample to another laboratory using a c501 module and the result was 6.9 ug feu/ml.On (b)(6) 2021 patient 2 initial result from the c501 module was 3.16 ug/ml.The sample was diluted and run on the c501 module: 1:3 result was 0.54 ug/ml, 1:10 result was 0.51 ug/ml.The c501 module serial number was (b)(4).

Manufacturer Narrative

The customer complained of discrepant results for a 3rd patient sample (patient 3) tested for d-dimer on the c501 module.On (b)(6)2021 the initial result was 1.31 ug/ml.The customer performed several dilutions with the following results: 1:3 result was 2.48 ug/ml.1:10 result was 4.36 ug/ml.1:20 result was 4.54 ug/ml.1:50 result was 2.99 ug/ml with a data flag.Increased mode result was 1.29 ug/ml.1:7 result was 4.2 ug/ml.1:8 result was 4.4 ug/ml.1:3 result was 2.49 ug/ml.1:10 result was 4.6 ug/ml.No sample material was available for further investigation.Based on the information provided, 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: 12893846
• MDR Text Key: 286937530
• Report Number: 1823260-2021-03525
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• 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
• Patient Age: 47 YR
• Patient Sex: Female