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	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The field service engineer checked the analyzer and did not find an issue.He performed a precision check that was successful.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant lipoprotein (a) gen.2 results from the cobas c 503 analytical unit.The initial result was 38 mg/dl.The repeat result was 80 mg/dl.The questionable result was not reported outside of the laboratory.The customer was not sure which result was correct.
Additional Manufacturer Narrative
Medwatch field b3 date of event was updated.Additional tests of the sample were performed on 04-aug-2024 on another line of the analyzer and were 46 mg/dl, 47 mg/dl, 89 mg/dl, and 49 mg/dl.The result of 49 mg/dl was believed to be correct.The investigation did not identify a product problem.The specific 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: 20091108
• Report Number: 1823260-2024-02495
• Device Sequence Number: 12675657
• 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): 10/22/2024

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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