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

Catalog Number	08463662001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation excluded reagent issues as there were no further cases reported and correct reruns were performed using the same reagent.The field service engineer (fse) inspected the analyzer and found the cells overflowing.He then readjusted the rinse volume in the cells.The fse also replaced the solenoid valves and sample probe springs; adjusted the high main pump pressure to the correct level; and adjusted the gear pump pressure and all the rinse stations for the probes' exterior wash.He confirmed that the assay and the analyzer were performing within specifications.The investigation determined the event was due to a service training-related issue.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable creatinine, phosphorus, and calcium results from four patient samples tested on the cobas pro c 503 analytical unit.It is unknown if the initial results were reported outside of the laboratory.Sample id (b)(6) the initial results were obtained on 16-jan-2024.The repeat results were obtained on (b)(6) 2024.The initial creatinine result from the analyzer was 65.7 umol/l.The repeat result from their other line was 85.7 umol/l.The initial phosphorus result from the analyzer was 0.710 mmol/l.The repeat result from their other line was 1.10 mmol/l.The initial calcium result from the analyzer was 1.72 mmol/l.The repeat result from their other line was 2.38 mmol/l.Sample id (b)(6) on (b)(6) 2024: the initial calcium result from the analyzer was 1.67 mmol/l.The repeat result from their other line was 2.35 mmol/l.Sample id (b)(6) the repeat results from their other line were obtained on (b)(6) 2024.The initial phosphorus result from the analyzer was 0.493 mmol/l.The first repeat result from their other line was 0.933 mmol/l.The second repeat result from their other line was 0.936 mmol/l.The initial calcium result from the analyzer was 1.42 mmol/l.The first repeat result from their other line was 2.35 mmol/l.The second repeat result from their other line was 2.35 mmol/l.Sample id (b)(6) the initial results from the analyzer were obtained on (b)(6) 2024.The repeat results from their other line were obtained on (b)(6) 2024.The initial calcium result from the analyzer was 1.62 mmol/l.The first repeat result from the analyzer was 2.21 mmol/l.The second repeat result from their other line was 2.21 mmol/l.The second repeat result from their other line was 2.24 mmol/l.The initial creatinine result from the analyzer was 65.6 umol/l.The first repeat result from the analyzer was 94.6 umol/l.The second repeat result from their other line was 91.7 umol/l.The third repeat result from their other line was 93.5 umol/l.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• Common Device Name: 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: 18704768
• Report Number: 1823260-2024-00439
• Device Sequence Number: 15040504
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K191899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown