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

Catalog Number	05852625190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 3 patients' samples tested with tina-quant lipoprotein (a) gen.2 (lpa2) assay on a cobas c503 analytical unit when compared to a different analytical unit.Sample 2 and sample 3 were plasma samples.Sample 1 (patient 1): initial result: 86 mg/dl (accompanied by a data flag and tested on the original c503).1st repeat result: 31 mg/dl (tested on the original c503 with 3 times dilution).2nd and 3rd repeat results were both 19 mg/dl (tested on another analytical unit).4th and 5th repeat results were both 19 mg/dl (tested on the original c503).Sample 2 (patient 2) was tested on (b)(6)2024: initial result: 39 mg/dl (tested on the original c503).1st repeat result: 49 mg/dl (tested on the original c503).2nd and 3rd repeat results were both 16 mg/dl (tested on another analytical unit).4th repeat result: 16 mg/dl (tested on the original c503).5th repeat result: 17 mg/dl (tested on the original c503).Sample 3 (patient 3) was tested on (b)(6)2024: initial result: 55 mg/dl (tested on the original c503).1st repeat result: 42 mg/dl (tested on the original c503).2nd repeat result: 28 mg/dl (tested on another analytical unit).3rd repeat result: 26 mg/dl (tested on another analytical unit).4th and 5th repeat results were both 28 mg/dl (tested on the original c503).For sample 2 and sample 3: no questionable results were reported outside the laboratory.The repeat results were deemed to be correct.Sample 2: the repeat result of 17 mg/dl was reported to the patient.Sample 3: the repeat result of 28 mg/dl was reported to the patient.
Additional Manufacturer Narrative
The lpa2 reagent expiration date was not provided.The cobas c503 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration wasn't verified prior to the event as the calibration recovery was only provided up to the (b)(6) 2024.The provided qc recovery was within the ranges.The field service engineer found no issues.He performed precision studies and the results were within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C 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: 20928443
• Report Number: 1823260-2024-03668
• Device Sequence Number: 8320113
• Product Code: DFC
• UDI-Device Identifier: 04015630929962
• UDI-Public: 04015630929962
• 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): 01/24/2025

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 Catalogue Number: 05852625190
• Device Lot Number: 784619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/24/2025
• 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