MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT C-REACTIVE PROTEIN IV; C REACTIVE PROTEIN TEST SYSTEM

Catalog Number	07876424190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).Per product labeling, there is no significant interference up to a hemolysis index of 1000 (approximate hemoglobin concentration: 622 mol/l or 1000 mg/dl).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one neonate patient sample tested with tina-quant c-reactive protein iv on a cobas 8000 c702 module.The customer suspects the sample hemolysis may have interfered with the assay.A first sample collected from the patient resulted in a crp value of 102 mg/l.The sample was not hemolyzed.A second sample collected from the patient resulted in a crp value of 54 mg/l.This result was questioned.A hemolysis index of 705 was measured from the sample.A third sample collected from the patient resulted in a crp value of 129 mg/l.This sample was not hemolyzed.
Additional Manufacturer Narrative
The customer deemed crp results of "around 100 mg/l" correct for the patient.The customer stated they use micro-cups or micro-cups on top of sample tubes when testing the patient samples.When programming these samples on the analyzer, the customer did not use the "micro cup" option on the sample order in order for the instrument to adapt sample pipetting.Per product labeling: "the instrument recognizes all standard containers except micro cups by their dimensions.For micro cups, you must select micro cup in workplace test selection or on the host." the investigation determined the issue is consistent with incorrect user handling of the device.

• Brand Name: TINA-QUANT C-REACTIVE PROTEIN IV
• Common Device Name: C REACTIVE PROTEIN 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: 19985033
• Report Number: 1823260-2024-02367
• Device Sequence Number: 19971254
• Product Code: DCN
• UDI-Device Identifier: 04015630946846
• UDI-Public: 04015630946846
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: K192072
• 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): 08/27/2024

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: 07876424190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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