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

Catalog Number	08463662001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable magnesium results for an unspecified number of patient samples on a cobas pro c 503 module.An example of discrepant results was provided for 1 patient sample.The initial result was 3.5 mg/dl.The sample was automatically repeated and the result was 5.8 mg/dl.The sample was tested on another analyzer and the results were 3.56 mg/dl and 3.49 mg/dl.It is unknown which result is correct.The results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The reagent lot number is 73167701 with an expiration date of 31-mar-2025.The investigation is ongoing.
Additional Manufacturer Narrative
The customer's calibration and qc results were ok.The field service representative found the reagent probe was out of alignment and the sonic wash was not clean and white crust was on the cover.He verified all of the wash stations and probe adjustments, reviewed maintenance handling with the customer (reagent probe replacement and cleaning the sonic wash station), and verified the instrument by performing a hardware check and precision testing.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.

• 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: 18591694
• Report Number: 1823260-2024-00239
• Device Sequence Number: 12793140
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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