MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TURBIDIMETRIC, TOTAL PROTEIN

Catalog Number	03333825190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tpuc3 total protein urine/csf gen.3 results for 4 patient cerebrospinal fluid samples on a cobas 8000 cobas c 502 module.The customer alleged that the total protein results were not plausible and did not match with other result findings as the total protein concentration was lower than the albumin measurement.On (b)(6) 2024, sample 1 had a tpuc3 result of 652.1 mg/l.The albumin result was 814 mg/dl.The sample was also tested on a siemens advia analyzer.The total protein result was 1282 mg/l and the albumin result was 814 mg/dl.On (b)(6) 2024, sample 1 was tested again and the tpuc3 result was 798 mg/l and the albumin result was 921 mg/l.On (b)(6) 2024, sample 2 had a tpuc3 result of 257.0 mg/l.The albumin result was 333.0 mg/dl.On (b)(6) 2024, sample 3 had a tpuc3 result of 279.7 mg/l.The albumin result was 361.0 mg/dl.On (b)(6) 2024, sample 4 had a tpuc3 result of 403.4 mg/l.The albumin result was 529.0 mg/dl.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The patient samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The patient samples were received for investigation.The customer's results were able to be confirmed.The investigation did not identify a product problem.The root cause of the event was found to be consistent with an unknown high-molecular substance in the patient samples.Per product labeling, "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.".

• Brand Name: TPUC3
• Common Device Name: TURBIDIMETRIC, TOTAL PROTEIN
• 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: 18816883
• Report Number: 1823260-2024-00614
• Device Sequence Number: 8307691
• Product Code: JGQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K141925
• 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): 11/01/2024

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: 03333825190
• Device Lot Number: 751584
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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