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

Catalog Number	08106126190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable tina-quant lipoprotein (a) gen.2 result from the cobas c 503 analytical unit for one patient.The initial result was 55 mg/dl.The first and second repeat results were 23 mg/dl.The third repeat result was 44 mg/dl.The fourth and fifth repeat results from another analyzer were 23 mg/dl.The result of 23 mg/dl was deemed to be correct.The questionable result was repeated as the customer was investigating fliers as this had been a recurring issue.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).Reagent issues were excluded as there were no further issues, and the correct repeat result was performed with the same reagent.The system was confirmed to be well adjusted and running within specifications.It was noted that the lab's humidity is significantly lower than specifications.It was also noted that the lab proactively pierces several of their calibration packs and may not use all of them.In the cone of the standy packs, the residual reagent dries out, and those sporadically pick up concentrates, causing higher reactions and results.The investigation determined that the root cause was consistent with the environmental conditions of the lab, along with lab-specific use of the calibration packs.

• 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: 23076298
• Report Number: 1823260-2025-03046
• Device Sequence Number: 4966005
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 887260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/17/2025
• 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