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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER; FIBRIN SPLIT PRODUCTS
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ROCHE DIAGNOSTICS D-DIMER; FIBRIN SPLIT PRODUCTS Back to Search Results
Catalog Number ASKU
Device Problem Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2021
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 a cobas integra 400 plus.No incorrect results were reported outside of the laboratory.The sample initially resulted in a d-dimer value of approximately 9 ug/ml.The sample was diluted 1:3 and repeated, resulting in a value of 29.24 ug/ml.The integra 400 plus analyzer serial number was (b)(4).
 
Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.
 
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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 Key13075051
MDR Text Key289966168
Report Number1823260-2021-03851
Device Sequence Number1
Product Code GHH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K062203
Number of Events Reported1
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
Report Date 12/23/2021
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 Catalogue NumberASKU
Device Lot Number56691201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2021
Initial Date FDA Received12/23/2021
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 Number1
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