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

Catalog Number	08106126190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The field service engineer (fse) confirmed the analyzer was operating within specification.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant lipoprotein (a) (lpa) gen.2 results for 8 patient samples on a cobas c 503 analytical unit.The customer has been repeating lpa testing since (b)(6) 2023 due to ongoing issues.On (b)(6) 2025, sample 1 had an initial result of 33.8 mg/dl with flag.The repeat result was 18.8 mg/dl.On (b)(6) 2025, sample 2 had an initial result of 93.4 mg/dl accompanied by a flag indicating the value is above the linearity/measuring range of the assay.The repeat result was 45.0 mg/dl with flag.On (b)(6) 2025, sample 3 had an initial result of 24 mg/dl with flag.The sample was repeated twice and the results were 93.4 mg/dl accompanied by a flag indicating the value is above the linearity/measuring range of the assay and 32 mg/dl.On (b)(6) 2025, sample 4 had an initial result of 25 mg/dl with flag.The repeat result was 46 mg/dl.On (b)(6) 2025, sample 5 had an initial result of 95 mg/dl on module 1.An automatic 1:3 dilution was performed on the sample and the repeat result was 32 mg/dl.The sample was repeated twice on module 2 and the result was 27 mg/dl and 24 mg/dl.The sample was repeated again on module 1 and the result was 30 mg/dl.On (b)(6) 2025, sample 6 had an initial result of 46 mg/dl on module 1.The repeat result was 39 mg/dl.The sample was repeated twice on module 2 and the result was 25 mg/dl and 26 mg/dl.The sample was repeated again on module 1 and the result was 28 mg/dl.On (b)(6) 2025, sample 7 had an initial result of 24 mg/dl with flag.The repeat result was 58 mg/dl.On (b)(6) 2025, sample 8 had an initial result of 25 mg/dl from module 2.The sample was repeated on module 1 and the result was 46 mg/dl.The sample was repeated twice on module 1 and the results were 45 mg/dl and 58 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
Based on the available data, a general reagent issue could be excluded.It was found that the customer's laboratory humidity level was below specification.It was also found that the customer has multiple reagent packs open on the analyzer but are not all used for testing on a daily basis, which could lead to evaporation, reagent concentration, and higher reaction levels and sample results.The root cause of the event was found to be consistent with laboratory specific environmental factors.No product problem was 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23488026
• Report Number: 1823260-2025-04535
• Device Sequence Number: 21472316
• Product Code: DFC
• UDI-Device Identifier: 07613336140833
• UDI-Public: 07613336140833
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08106126190
• Device Lot Number: 88726001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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