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

Catalog Number 03263991190

Device Problem Low Test Results (2458)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The c502 module serial number was (b)(6).Calibration and qc were acceptable.The customer had no issues with other patient samples.The customer cleaned the sample probe and performed a sample probe wash.The field service engineer (fse) found an issue with the rinse station leading to water overflow.The fse replaced the rinse tubing.The customer had no further issues after the service visit.The investigation is ongoing.

Event Description

The initial reporter complained of a discrepant low result for 1 patient sample tested for cobas integra creatinine plus ver.2 assay (crep2) on a cobas 8000 c 502 module.The initial result was 0.55 mg/dl.The sample was repeated twice with results of 1.22 mg/dl and 1.17 mg/dl.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The crep2 reagent lot number was 734446 with an expiration date of 31-mar-2024.A reagent issue can be excluded.The investigation determined the issue identified and resolved by the fse (leaky cell rinse tubes) was the cause of the event.The service maintenance actions resolved the 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18329227
• MDR Text Key: 330958868
• Report Number: 1823260-2023-04014
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: K100853NA
• 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: 12/22/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 03263991190
• Device Lot Number: 734446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• 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