MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 311 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Catalog Number 04826876001

Device Problems Low Test Results (2458); Low Readings (2460)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The crp4, alp, ggt, bil and crea reagents' lot numbers and expiration dates were not provided.The customer suspected a sample-related issue for sample 1.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's sample tested with c-reactive protein iv (crp4) assay and 1 patient's sample tested with alkaline phosphatase (alp) assay and 1 patient's sample tested with gamma-glutamyltransferase (ggt) assay and 1 patient's sample tested with bilirubin (bil) assay and 1 patient's sample tested with creatinine (crea) assay on a cobas 4000 c311 stand alone system.Sample 1 was tested for crp4: initial result: 0 mg/l.This result was reported outside the laboratory by auto-validation.Repeat result: 40 mg/l.Sample 2 was tested for alp: initial result: 1 u/l.Repeat result: 139 u/l.Sample 3 was tested for ggt: initial result: 1 u/l.Repeat result: 35 u/l.Sample 4 was tested for bil: initial result: 0 umol/l.Repeat result: 20 umol/l.Sample 5 was tested for crea: initial result: -1 umol/l.Repeat result: 102 umol/l.All initial results were outside the measuring range and they were not accompanied by data flags.

Manufacturer Narrative

Medical device problem code (a code) was updated.The data was not provided by the customer.The issue was confirmed as a single event.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C 311 ANALYZER
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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
• MDR Report Key: 17867474
• MDR Text Key: 324875310
• Report Number: 1823260-2023-03177
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630925551
• UDI-Public: 04015630925551
• Combination Product (y/n): Y
• Reporter Country Code: FI
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04826876001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• 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