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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable high calcium gen 2 (ca2) result from the cobas pro c 503 analytical unit.The customer could not provide specific patient data but stated the results are 1.0 - 1.5 mg/dl different between the two cobas pro c 503 analytical unit at the customer site.The low repeat results from cobas pro c 503 analytical unit 22k8-01 were believed correct and corrected reports were issued.
Additional Manufacturer Narrative
The reagent lot number was 59518701 with an expiration date of 31-jul-2024.The field service engineer found there was insufficient washing of the sample probe and reagent probe carryover.He cleaned the exterior of the sample probe and removed a large crusty buildup.He flushed the sample probe and soaked the sample and reagent probes.He performed air purges, checked the inlet water pressure and gear pump pressure, adjusted the rinse mechanism dispense levels, adjusted the sample probe rinse station, adjusted the external rinse levels for all probes, and performed adjustments for all probes.He adjusted the cell detergent consumption levels, added reagent probe special washes, performed hardware checks, and performed precision testing which was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
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: 18624385
• Report Number: 1823260-2024-00294
• Device Sequence Number: 12612009
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 05/22/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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