MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRPHS; CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Catalog Number	04628918190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for crphs on a cobas 6000 c501 module.The initial result was 589.14 mg/l accompanied by an invalidating data flag.The sample was repeated with a 1:20 dilution and the result was 281.10 mg/l.The sample was then repeated using "ifi" technology and the result was 137.4 mg/l.This result was believed to be correct.On (b)(6) 2023 the sample was repeated and the result was 580.97 mg/l accompanied by an invalidating data flag.The sample was repeated again with a 1:20 dilution and the result was 275.35 mg/l.Additional results were provided from 28-sep-2023: the result was 596.94 mg/l accompanied by an invalidating data flag.The repeat result in decreased mode was 272.58 mg/l.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).
Additional Manufacturer Narrative
Calibration and qc were acceptable.No issues were identified during a review of the alarm trace data.The sample concentration for the patient was relatively high.Product labeling states: "determine samples having higher concentrations via the rerun function.Dilution of samples via the rerun function is a 1:15 dilution." the customer used a 1:20 dilution.The sample was repeated using "ifi" technology.Different analytical methods may produce different results.The investigation did not identify a product problem.The event was due to a sample handling issue (non-validated dilution).

• Brand Name: CRPHS
• Common Device Name: CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
• 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: 17965983
• Report Number: 1823260-2023-03350
• Device Sequence Number: 18059924
• Product Code: NQD
• UDI-Device Identifier: 04015630921508
• UDI-Public: 04015630921508
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K053603
• 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): 12/05/2023

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 04628918190
• Device Lot Number: 72884801
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CIPROFLOXACIN.
• Patient Age: 38 YR
• Patient Sex: Female