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

Catalog Number	03001245322
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complete e1 initial reporter establishment name is "(b)(6): the cobas 4000 c311 stand alone system serial number was (b)(6).The investigation was unable to determine a specific root cause as no sample material was available for further investigation.The discrepancy between d-dimer assays is consistent with differences in antibody specificity, especially concerning the preference for high or low molecular weight fibrin derivatives.There was no evidence to reasonably suggest there was a device malfunction.
Event or Problem Description
There was an allegation of questionable low tina-quant d-dimer results from the cobas 4000 c311 stand alone system when compared to a reference laboratory.Of the data provided, the result for one sample were a reportable malfunction.The initial result was 0.35 (<0.5) g/ml.The result from a reference laboratory using a sta compact max analyzer was 2.00 g/ml.

• Brand Name: TINA-QUANT D-DIMER
• Common Device Name: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25134911
• Report Number: 1823260-2026-01830
• Device Sequence Number: 18505189
• Product Code: GHH
• UDI-Device Identifier: 04015630914593
• UDI-Public: 04015630914593
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K011143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03001245322
• Device Lot Number: 942932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female