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

Model Number	CREP G2
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Precision testing was performed with acceptable results.The field service engineer performed sample probe wash and air purge.The investigation is ongoing.(b)(4).
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the crep2 (creatinine plus ver.2) assay on a cobas 6000 c 501 module, serial number (b)(4).The sample initially resulted in an invalid crep2 result, accompanied by a data flag.The sample was re-centrifuged and then repeated, resulting in a crep2 value of 0.92 mg/dl.This result was reported outside of the laboratory and questioned by the physician.The sample was repeated a second time, resulting in a crep2 value of 1.58 mg/dl.This result fits the clinical picture of the patient.
Additional Manufacturer Narrative
A review of the initial data flag indicates that a sample clot was detected.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a sample quality-related issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16523478
• Report Number: 1823260-2023-00763
• Device Sequence Number: 2393569
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 04/07/2023

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: 06/30/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 03263991190
• Device Lot Number: 663665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/07/2023
• 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
• Patient Sex: Unknown