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

Catalog Number 03263991190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

The c311 analyzer serial number was (b)(6).The field service engineer (fse) cleaned and checked various parts of the instrument.The customer has not complained of any further issues.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant low results for 2 patient urine samples tested for cobas integra creatinine plus ver.2 assay (crep2) on a cobas c 311 analyzer.Patient (b)(6) initial result was 4.30 mg/dl.The repeat result was 10.61 mg/dl.Patient (b)(6) initial result was 13.20 mg/dl.The repeat result was 39.64 mg/dl.The samples were repeated as the initial results either did not correspond to the patient¿s history or they were too low.

Manufacturer Narrative

Section d, device identification section was updated.Relevant fields of sections d and g were updated.The crep2 reagent lot number was 73444601 with an expiration date of 31-mar-2024.Based on the pictures provided, the customer is not performing instrument maintenance as recommended.Pipettor probes and rinse nozzles should be cleaned daily.Rinse stations, cell covers and reaction parts should be cleaned weekly.After the instrument was cleaned, the customer had no further issues.The investigation did not identify a product problem.

• 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: 18659213
• MDR Text Key: 334758854
• Report Number: 1823260-2024-00353
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): Y
• Reporter Country Code: PE
• PMA/PMN Number: K060373
• 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: 02/26/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 73444601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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