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

Catalog Number	07876432190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) found a dirty filter and advised the customer to order a new one.The fse also noticed mold in the distilled water bottle and performed decontamination, replaced a syringe, and performed precision checks successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable crpl4 c-reactive protein gen.4 results for 1 patient sample on a cobas c 111 analyzer.On (b)(6) 2023, the initial crpl4 result was 52 mg/dl.On (b)(6) 2023, the patient presented back at the emergency room with abdominal pain and this prompted the customer to repeat the original sample.The sample was repeated three times and the results were 0.67 mg/dl, 58 mg/dl, and 133 mg/dl.
Additional Manufacturer Narrative
The root cause of the event was found to be poor water quality at the customer's site.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.No product problem was identified.

• 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: 17764674
• Report Number: 1823260-2023-03003
• Device Sequence Number: 12555807
• Product Code: DCN
• UDI-Device Identifier: 04015630946853
• UDI-Public: 04015630946853
• Combination Product (Y/N): Y
• Initial Reporter Country: BK
• 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): 10/10/2023

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: 07876432190
• Device Lot Number: 66135401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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: Female