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	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant lipoprotein (a) gen.2 results for three patient samples on a cobas c 503 analytical unit.An example of discrepant results: the initial result was 44 mg/dl.The sample was repeated on another module.The repeated results were 26 mg/dl and 27 mg/dl.The result of 27 mg/dl was believed to be correct.The sample was repeated due to the customer performing duplicate testing for lipoprotein results.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
General reagent issues were excluded.The instrument was confirmed to be performing within specification.The investigation found that several c-packs were proactively pierced for qc use.On average, only two might be used per day.In the standby packs, the residual reagent dried out and sporadically picked up concentrates that caused higher reactions and results.The investigation also found the laboratory's humidity was significantly lower than specifications.The investigation determined the issue was due to environmental/humidity issues.

• 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: 20833967
• Report Number: 1823260-2024-03505
• Device Sequence Number: 8865566
• 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): 03/05/2025

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: 724019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/05/2025
• 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