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	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lpa2 reagent lot number was 80828001 with an expiration date of 31-dec-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for an unspecified number of patient samples tested with tina-quant lipoprotein (a) gen.2 (lpa2) assay on a cobas c503 analytical unit.The following examples of discrepant results were provided: sample 1: initial result from the analyzer: 78 mg/dl 1st repeat result from the analyzer: 62 mg/dl.2nd and 3rd repeat results from another c 503 analyzer: both 50 mg/dl.4th and 5th repeat results from the analyzer: both 50 mg/dl.Sample 2: initial result from the analyzer: 62 mg/dl 1st repeat result from the analyzer: 48 mg/dl.2nd repeat result from the other c503 analyzer: 30 mg/dl.3rd repeat result from the other c503 analyzer: 28 mg/dl.4th repeat result from the analyzer: 29 mg/dl.Sample 3: initial result from the analyzer: 80 mg/dl.1st repeat result from the analyzer: 62 mg/dl.2nd and 3rd repeat results from the other c503 analyzer: both 49 mg/dl.The repeat results were deemed to be correct.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The calibration was last performed on 26-dec-2024.Qc recovery was within the customer's established ranges.There was no indication of a performance issue with the reagent.The field service engineer checked the instrument and found no root cause for the issue.He then performed precision studies and they were within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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 46250-0457
• MDR Report Key: 21453152
• Report Number: 1823260-2025-00534
• Device Sequence Number: 20632203
• 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): 03/13/2025

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: 12/31/2025
• Device Catalogue Number: 08106126190
• Device Lot Number: 80828001
• 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: 03/06/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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