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

Model Number CREP G2

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 311079188
• Report Number: 1823260-2023-00763
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/12/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1