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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c701 module serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for tina-quant lipoprotein (a) gen.2 (lpa2) on a cobas 8000 cobas c 701 module.The initial result was 236 nmol/l.This result was questioned by the physician, and the sample was repeated.The repeat result was 248.0 nmol/l, accompanied by an invalidating data flag.The repeat result was 1213.5 nmol/l.The sample was repeated with a 1:3 dilution, and the result was 1206.0 nmol/l, accompanied by an invalidating data flag.The sample was repeated with a 1:5 dilution, and the result was 1431.5 nmol/l, accompanied by an invalidating flag.The sample was repeated with a 1:20 dilution, and the result was 951.1 nmol/l.
Additional Manufacturer Narrative
It was found that the sample was centrifuged for 7 minutes; this is too short.There were frequent sample-quality-related alarms on the alarm trace data.The investigation determined the event was due to pre-analytical handling issues.

• 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: 24681101
• Report Number: 1823260-2026-01056
• Device Sequence Number: 9976463
• 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): 04/23/2026

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: 05852633190
• Device Lot Number: 938898
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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: Unknown