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	01/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable low calcium gen (ca2) results from the cobas pro c 503 analytical unit.Patient 1 initial result was 5.63 mg/dl and the repeat result on the same analyzer was 7.34 mg/dl.The repeat result on the other cobas pro c 503 analytical unit was 7.34 mg/dl.Patient 2 initial result was 5.8 mg/dl and the repeat result on the same analyzer was 7.8 mg/dl.The repeat result on the other cobas pro c 503 analytical unit was 8.1 mg/dl.The result of 7.8 mg/dl.Was believed correct.
Additional Manufacturer Narrative
The reagent lot number was 70571101 with an expiration date of 31-may-2024.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer found there was insufficient washing of the sample probe.He cleaned and flushed the probes, performed air purges, and checked the inlet water pressure and gear pump pressure.He adjusted the rinse mechanism dispense levels, probe rinse station, and external rinse levels.He performed horizontal and vertical adjustments for the probes.He adjusted the cell detergent consumption and the cell detergent consumption levels.He added probe special washes and performed a hardware check and precision testing that was acceptable.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: 18624390
• Report Number: 1823260-2024-00293
• Device Sequence Number: 20682153
• 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): 02/21/2024

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: 02/19/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/21/2024
• 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: Male