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); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glucose hk gen.3 reagent lot number is 73448901 with an expiration date of 31-oct-2024.The calcium gen.2 reagent lot number is 75546501 with an expiration date of 31-jan-2025.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable glucose hk gen.3 and calcium gen.2 results for 1 patient sample on a cobas c 503 analytical unit.The initial glucose result was 26 mg/dl.The repeated glucose result was 122 mg/dl.The initial ca result was 5.59 mg/dl.The repeated ca result was 8.51 mg/dl.The repeated results were believed to be correct.The questionable results were not reported outside of the laboratory.The user questioned the initial glucose result and repeated the sample on another analyzer.
Additional Manufacturer Narrative
The field service engineer found the sample probe was out of adjustment causing it to not be washed properly.He replaced the probe and completed all adjustments.He ran a precision check, calibrations, and controls with acceptable results.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: 18806083
• Report Number: 1823260-2024-00587
• Device Sequence Number: 7294592
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 02/04/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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 Age: 15 YR
• Patient Sex: Male