MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT APOLIPOPROTEIN A-1 VER.2; ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08105448190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for tina-quant apolipoprotein a-1 ver.2 (apoat) on a cobas c 503 analytical unit.The initial result was 0.489 g/l.The sample was repeated by a competitor method and the result was "discrepant." the specific result was not provided.The sample was repeated on the c503 analyzer using a 1:2 dilution and the result was 0.85 g/l.A new sample was obtained and the initial result on the c503 analyzer was 0.8 g/l.The sample was repeated using a 1:2 dilution and the result was 0.924 g/l.
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
Qc was within the acceptable range.No issues were identified with the customer's current calibration.Many sample short alarms were observed on the alarm trace data.The specific cause of the event could not be determined, however, based on the information provided, the event is consistent with an issue with the sample probe due to preanalytical handling issues and/or insufficient probe wash.The investigation did not identify a product problem.

• Brand Name: TINA-QUANT APOLIPOPROTEIN A-1 VER.2
• Common Device Name: ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM
• 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: 19972879
• Report Number: 1823260-2024-02347
• Device Sequence Number: 20601824
• Product Code: DER
• UDI-Device Identifier: 07613336133521
• UDI-Public: 07613336133521
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K013249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 08105448190
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/03/2024
• 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