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	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calcium reagent lot number is 744169, the phosphorus reagent lot number is 736783, and the glucose reagent lot number is 715245.The reagent expiration dates were requested, but not provided.Calibration and controls were acceptable.There was no indication of a reagent performance issue.Upon review of the alarm trace, multiple abnormal aspiration alarms were observed near the time of the event.The field service engineer determined rinse levels were misadjusted and a probe was not being washed properly.The rinse levels were adjusted.A solenoid valve and needle valve were replaced.A probe was adjusted and it was cleaned since it had buildup on it.Mechanism checks were performed.The customer ran controls and the results were acceptable.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ca2 (calcium), phos2 (phosphorus), and cobas integra glucose hk gen.3 on a cobas pro c 503 analytical unit.No questionable results were reported outside of the laboratory.The sample was repeated due to low test results.The repeat results were deemed correct.The sample resulted in the following initial values: calcium = 5.17 mg/dl phosphorus = 0.746 mg/dl glucose = 112 mg/dl.The sample repeated with the following values: calcium = 8.11 mg/dl phosphorus = 1.05 mg/dl glucose = 147 mg/dl.

• 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: 18661712
• Report Number: 1823260-2024-00367
• Device Sequence Number: 18158575
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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: 01/30/2024
• Initial Report FDA Received Date: 02/07/2024
• 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