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	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lpa2 tina-quant lipoprotein (a) gen.2 results for 3 patient samples on two cobas c 503 analytical unit.The customer had been having issues with high lpa2 results for several months which prompted them to repeat the patient samples.On (b)(6) 2024, sample 1 had an initial plasma lpa result of135 mg/dl on analyzer serial number (b)(6).The sample was repeated three times and the results were 108 mg/dl, 42 mg/dl with an automatic 1:3 decreased dilution, and 60 mg/dl.The sample was also repeated twice on analyzer serial number (b)(6) and the results were 33 mg/dl and 38 mg/dl.The result of 38 mg/dl was deemed correct.On (b)(6) 2024, sample 2 had an initial plasma lpa result of 73 mg/dl on analyzer serial number (b)(6).The sample was repeated and the result was 57 mg/dl.On(b)(6) 2024, the sample was repeated twice on analyzer serial number (b)(6) and the results were 25 mg/dl and 24 mg/dl.The sample was repeated on analyzer serial number (b)(6) again and the result was 24 mg/dl.The result of 24 mg/dl was deemed correct.On (b)(6) 2024, sample 3 had an initial serum lpa result of 135 mg/dl on analyzer serial number (b)(6).The sample was repeated and the result was 61 mg/dl with an automatic 1:3 decreased dilution.The sample was repeated twice on analyzer serial number (b)(6) and the results were 61 mg/dl and 61 mg/dl.The sample was repeated twice on analyzer serial number (b)(6) again and the results were 61 mg/dl and 60 mg/dl.The result of 61 mg/dl was deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial numbers are (b)(6) and (b)(6).The field service engineer (fse) performed a precision check successfully.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on (b)(6) 2024 and it was acceptable.The qc recovery was within the customer's established ranges.There was no indication of a performance issue with the reagent.The alarm trace showed multiple alarms (abnormal liquid level alarm, abnormal aspiration (sample pipetter) alarm, and remaining volume decrease alarm) on the day of the event.The field service engineer evaluated the instrument and found no specific cause for the event.He verified that the instrument was performing within specifications.The investigation did 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: 20758395
• Report Number: 1823260-2024-03407
• Device Sequence Number: 20938161
• Product Code: DFC
• UDI-Device Identifier: 07613336140833
• UDI-Public: 07613336140833
• 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): 12/27/2024

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: 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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