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	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c503 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples 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 initial values were accompanied by data flags and the samples were then automatically repeated on the analyzer.The first sample initially resulted in a lipoprotein (a) value of 58 mg/dl and it automatically repeated as 49 mg/dl.The sample was repeated twice on a second analyzer, resulting in values of 28 mg/dl and 29 mg/l.The sample was also repeated on the complained analyzer, resulting in a value of 28 mg/dl.The 28 mg/dl value was deemed correct.The second sample initially resulted in a lipoprotein (a) value of 79 mg/dl and it automatically repeated as 65 mg/dl.The sample was repeated twice on a second analyzer, resulting in values of 52 mg/dl and 52 mg/l.The 52 mg/dl value was deemed correct.
Additional Manufacturer Narrative
Calibration and controls were acceptable.There is not indication of a reagent performance issue.The field service engineer performed precision studies and these were acceptable.Quality controls recovered within range.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: 19073830
• Report Number: 1823260-2024-01081
• Device Sequence Number: 4683276
• 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): 04/17/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 08106126190
• Device Lot Number: 73658701
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/17/2024
• 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