MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number C503

Device Problem Unable to Obtain Readings (1516)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with bilirubin total (bil-t) on a cobas pro c 503 analyzer.The initial result was (b)(6) ¿mol/l and the repeat result was (b)(6) mol/l.The initial result for the second sample (new blood drawn) was (b)(6) mol/l.The bil-t reagent lot number was 64219601 and the expiration date was 31-sep-2023.The questionable results were reported outside of the laboratory and it was questioned by the pediatrician.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined due to the limited amount of information available for investigation.Based on the pre-analytical report, the centrifugation conditions are lower than 3 minutes and the microtube was used without a rack adapter.In general, the quality control trace shows a fluctuation of the quality control recovery for both the c1 module and the c2 module of the cobas c 503 analytical unit.It was requested but not informed in which module (c1 or c2) the alleged erroneous result occurred.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15920600
• MDR Text Key: 308144636
• Report Number: 1823260-2022-03873
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C503
• Device Catalogue Number: 09502807001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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
• Patient Age: 2 DA