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

Model Number C503

Device Problems False Positive Result (1227); High Readings (2459)

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

Event Date 11/20/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable li lithium results for 1 patient sample on a cobas pro c 503 analytical unit.On (b)(6) 2022, the initial lithium result was 1.61 mmol/l.The initial result was reported outside of the laboratory.The doctor questioned the high result and the sample was repeated the next day.On (b)(6) 2022, the repeat result was 0.10 mmol/l.The repeat result was deemed correct.The reagent lot and expiration date were requested but not provided.

Manufacturer Narrative

The alarm trace did not contain a conspicuous event.The field service engineer (fse) did not find any hardware issues with the analyzer.The fse performed precision and carry-over tests and checked the probes and cell wash volume.The customer performed calibration and qc successfully.The investigation is ongoing.

Manufacturer Narrative

No further issues were reported after the service visit.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 15977636
• MDR Text Key: 308093425
• Report Number: 1823260-2022-04007
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• 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: 22 YR
• Patient Sex: Male