MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT ¿2-MICROGLOBULIN; BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08047430190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant 2-microglobulin results for 2 patient samples on a cobas 8000 c 502 module.Patient 1: the initial result was invalidated due to having a data flag.The sample was automatically diluted and the result was 6.4 mg/l.The sample was manually diluted and the result was 16.8 mg/l.This result was believed to be correct.Patient 2: the initial result was invalidated due to having a data flag.The sample was automatically diluted and the result was 7.2 mg/l.The sample was manually diluted and the result was 16.8 mg/l.This result was believed to be correct.The samples were repeated due to the initial result having a data flag, and higher results were expected.The questionable results were not reported outside the laboratory.
Additional Manufacturer Narrative
The calibration and qc were within specifications.The field service representative correctly programmed all special wash functions before pipetting.Calibrations and qcs were performed and the results were within specifications.No further issues were reported by the customer.The investigation determined the service actions resolved the issue.The investigation did not identify a product problem.

• Brand Name: TINA-QUANT ¿2-MICROGLOBULIN
• Common Device Name: BETA-2-MICROGLOBULIN 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: 20461807
• Report Number: 1823260-2024-02986
• Device Sequence Number: 21046823
• Product Code: JZG
• UDI-Device Identifier: 07613336119990
• UDI-Public: 07613336119990
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K980724
• 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): 11/26/2024

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 08047430190
• Device Lot Number: 76651501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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 Age: 70 YR
• Patient Sex: Male