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	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).
Event or Problem Description
There was an allegation of questionable lpa2 tina-quant lipoprotein (a) gen.2 results for several patient plasma samples on a cobas pure c 303 analytical unit.The customer provided examples for 2 patient samples.On (b)(6) 2024, sample 1 had an initial lpa2 result accompanied by a flag indicating the value is above the linearity/measuring range of the assay.The sample was repeated and the result was 707 nmol/l.The customer questioned the result as it did not match the patient's clinical history.On (b)(6) 2024, the sample was repeated and the result was 437 nmol/l accompanied by a flag indicating the value is above the linearity/measuring range of the assay.The sample was auto-repeated and the result was 493 nmol/l.A 1:3 dilution was made from the patient sample and tested and the result was 441 nmol/l.The patient also had another sample result of 669 nmol/l.Clarification on the date of testing and if it was obtained from a sample from the same collection was requested but not provided.
Additional Manufacturer Narrative
The customer reported the lpa2 tina-quant lipoprotein (a) gen.2 result of 493 nmol/l.The lpa2 result of 669 nmol/l was obtained on (b)(6) 2024 and was from a new patient sample.The investigation found that the discrepant results were from vascular surgery patients who had very high lpa2 concentrations above the measuring range.All samples were above or very close to the high dose hook limit of the assay.Per product labeling, "high dose hook-effect: no false result occurs up to a lipoprotein (a) concentration of 450 nmol/l." based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.
Additional Manufacturer Narrative
Medwatch field h2 type of follow up was updated for the initial follow-up report submitted.

• 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: 20313080
• Report Number: 1823260-2024-02793
• Device Sequence Number: 12787087
• Product Code: DFC
• UDI-Device Identifier: 07613336140833
• UDI-Public: 07613336140833
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 12/03/2024

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: 08/31/2025
• Device Catalogue Number: 08106126190
• Device Lot Number: 78461901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 11/18/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/02/2024; 12/03/2024
• 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