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	06/21/2025
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.The initial result for sample (b)(6) on (b)(6) 2025 was 31 mg/dl, and a repeat result of 26 mg/dl.There was another repeat result of 15 mg/dl from another analyzer.With additional repeat results on (b)(6) 2025 of 15 mg/dl from another analyzer and a result of 14 mg/dl from the initial analyzer.The initial result for sample (b)(6) on (b)(6) 2025 was 116 mg/dl, and a repeat result of 56 mg/dl.There were two additional repeat results of 50 mg/dl and 49 mg/dl from another analyzer.On (b)(6) 2025, on the same initial analyzer, there was a result of 48 mg/dl.The initial result for sample (b)(6) on (b)(6) 2025 was 38 mg/dl, and a repeat result of 32 mg/dl.There were 2 additional repeat results from another analyzer of 21 mg/dl and 21 mg/dl.There was also an additional repeat result from the initial analyzer of 22 mg/dl.The questionable results were not released outside of the laboratory.The initial results were repeated because the customer questioned them.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
There was not a general reagent issue, as there were no further events, and the correct rerun was performed using the same reagent.The system was confirmed to be well adjusted and running within specifications.The lab's humidity is significantly lower than the specification.The investigation determined that the root cause is the lab's environment, as well as how the lab specifically uses the control 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: 22554045
• Report Number: 1823260-2025-02219
• Device Sequence Number: 9576978
• 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): 09/24/2025

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: 10/31/2023
• Device Catalogue Number: 08106126190
• Device Lot Number: 63486601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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