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	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with tina-quant lipoprotein (a) gen.2 on a cobas c 503 analytical unit.No questionable results were reported outside of the laboratory.The user has been repeating all lipoprotein (a) testing in duplicate due to ongoing issues.The sample initially resulted in a lipoprotein (a) value of 76.9 mg/dl with a data flag.The sample was repeated twice on the same analyzer, resulting in lipoprotein (a) values of 62.7 mg/dl with a data flag and 46.9 mg/dl with a data flag.The repeat value of 46.9 mg/dl was deemed correct.The sample was repeated twice on a second analyzer, resulting in lipoprotein (a) values of 53 mg/dl with a data flag and 52 mg/dl with a data flag.
Additional Manufacturer Narrative
The serial number of the c503 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Quality controls were acceptable.There was no indication of a reagent performance issue.The field service engineer could not determine a cause.Precision studies were performed and recovered within guidelines.Controls recovered within established ranges.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 19332816
• Report Number: 1823260-2024-01472
• Device Sequence Number: 16896366
• Product Code: DFC
• UDI-Device Identifier: 07613336140833
• UDI-Public: 07613336140833
• Combination Product (Y/N): Y
• 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): 06/24/2024

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 Catalogue Number: 08106126190
• Device Lot Number: 736587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/24/2024
• 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