MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT LIPOPROTEIN (A) GEN.2; LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	05852633190
Medical Device Problem Codes	Low Test Results (2458); Chemical Problem (2893); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 ise 1800 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable tina-quant lipoprotein (a) gen.2 result from the cobas 8000 ise 1800 module.The initial result was 230 nmol/l, and the repeat result on a siemens analyzer was 579 nmol/l.There was another test completed on the c 701 from the same sample with dilution that gave a result of > test.The questionable result was repeated because it did not match the previous results.The results of 579 nmol/l matched with previous results.
Additional Manufacturer Narrative
Based on the measuring range of the assay, the result from the roche assay range is considered to be correct.Based on the diluted result that measured higher than the undiluted result, interference is potentially a root cause.Additional dilution steps or a sample were needed for an investigation and were not received.No additional root cause investigation was able to be completed.The case is closed with no product problem identified.

• Brand Name: TINA-QUANT LIPOPROTEIN (A) GEN.2
• Common Device Name: LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21433840
• Report Number: 1823260-2025-00518
• Device Sequence Number: 11849463
• Product Code: DFC
• UDI-Device Identifier: 04015630930586
• UDI-Public: 04015630930586
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122722
• 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,Followup
• Report Date (Section B): 03/11/2025

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: 05852633190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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: Unknown