MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CREATININE PLUS VER.2 ASSAY; ENZYMATIC METHOD, CREATININE

Catalog Number	03263991190
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The competitor method was siemens.Product labeling states: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results." and "determine samples having higher concentrations via the rerun function.Dilution of samples via the rerun function is a 1:4 dilution." sample material was requested for investigation.
Event or Problem Description
The initial reporter questioned results for 1 patient tested for cobas integra creatinine plus ver.2 assay (crep2) on a cobas 6000 c501 module.The initial result was [-] 2.94 mg/dl with a data flag.The repeat result from a different analyzer was [-] 3.28 mg/dl with a data flag.The result in decreased mode was 4.39 mg/dl.A new serum sample was obtained and the initial result was [-] 2.08 mg/dl with a data flag.The plasma k2 edta result was [-] 1.76 mg/dl with a data flag.The calculated result from a 1:2 dilution was 3 mg/dl.The result from another laboratory using creatinine jaffe was 1.17 mg/dl.The result from another laboratory using a competitor method was 1.34 mg/dl.
Additional Manufacturer Narrative
The patient sample was received for investigation.The sample was run on a c501 module and a c503 module with the following assays: crea2, crea jaffe, iga, igg, igm, kappa, lambda, apo a1, and serum index.Tests were performed with the crea2 assay on both modules to see if there was a difference between the instruments.The crea2 results from both instruments were "

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• Common Device Name: ENZYMATIC METHOD, CREATININE
• 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: 18741975
• Report Number: 1823260-2024-00490
• Device Sequence Number: 7229045
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K024098
• 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): 03/25/2024

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: 06/30/2024
• Device Catalogue Number: 03263991190
• Device Lot Number: 74766501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/25/2024
• 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
• Patient Sex: Male