MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS CREATININE PLUS VER.2 ASSAY; CREATININE TEST SYSTEM

Catalog Number	08057524190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's c 503 analyzer is (b)(6).The serial number of the unknown roche analyzer was requested, but not provided.Competitor 1 is abbott and competitor 2 is abl radiometer.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of samples from one patient tested with the cobas creatinine plus ver.2 assay on a cobas c 503 analytical unit and an unknown roche analyzer at another site.Creatinine results measured on the customer's c 503 analyzer have results close to 170 umol/l.When samples from the patient are tested in another laboratory on a competitor system (competitor 1), the creatinine results are close to 60 - 70 umol/l.The customer provided an example of results from one of the patient's samples.When this sample was tested on the customer's c 503 analyzer, the creatinine result was > 175 umol/l.When tested on a competitor system (competitor 2) in the customer's laboratory, the creatinine result is > 71 umol/l.When tested on an uknown roche system in another laboratory, the creatinine result is > 174 umol/l.A different sample collected from the patient was tested in another laboratory using a competitor system (competitor 1) and the creatinine result was 63 umol/l.
Additional Manufacturer Narrative
The patient sample was tested on a vitros analyzer, resulting in a creatinine value of 61 umol/l.The patient had a urine creatinine measurement of 2.6 mmol/l on (b)(6) 2024.Medwatch fields d4 and d10 have been updated.
Additional Manufacturer Narrative
Based on the provided information, a general reagent issue can be ruled out as calibration and qc data are acceptable.The medications the patient was taking are unlikely to interfere with the assay.The patient has monoclonal gammopathy.Per product labeling, "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.".The investigation did not identify a product issue.

• Brand Name: COBAS CREATININE PLUS VER.2 ASSAY
• Common Device Name: CREATININE 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: 19477278
• Report Number: 1823260-2024-01692
• Device Sequence Number: 4036156
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/12/2024

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: 08057524190
• Device Lot Number: 794463
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/13/2024; 07/11/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/05/2024; 07/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APIXABAN; COLECALCIFEROL; EFFERALGAN; OMEPRAZOLE SOTALOL; SERESTA
• Patient Sex: Unknown