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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lipoprotein a reagent lot number was 73658701 with an expiration date of 31-dec-2024.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with lpa2 (lipoprotein a) on a cobas c 503 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in a lipoprotein a value of 52.1 mg/dl with a data flag.The sample was automatically repeated by the analyzer, resulting in a value of 46 mg/dl.The sample was repeated three times on a second analyzer, resulting in values of 35 mg/dl, 35 mg/dl, and 34.0 mg/dl with a data flag.The repeat value of 35 mg/dl was deemed correct.
Additional Manufacturer Narrative
Calibration and controls were acceptable.The field service engineer performed precision studies and these were acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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 46250-0457
• MDR Report Key: 18959781
• Report Number: 1823260-2024-00870
• Device Sequence Number: 4579656
• 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
• 2 Devices were Involved in the Event: 1 2

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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/22/2024
• 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