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

Model Number	C503
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results from the cobas pro c 503 analytical unit.Patient 1 initial bild2 (direct bilirubin) result was 0.714 mg/dl and the repeat result was 0.0922 mg/dl.Patient 2 initial gluc3 (glucose) result was 5.72 mg/dl and the repeat result was 85.5 mg/dl.The questionable results were not reported outside of the laboratory.The direct bilirubin reagent lot number was 63837501 with an expiration date of 31-aug-2023.The glucose reagent lot number was 61404201 with an expiration date of 31-may-2023.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc data were acceptable, therefore a general reagent issue could be excluded.The alarm trace showed several abnormal aspiration and clot alarms.Therefore, the issue was consistent with a hardware/maintenance issue, and also with a sample quality (preanalytic) 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15826411
• Report Number: 1823260-2022-03683
• Device Sequence Number: 5998746
• Product Code: JJE
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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 Model Number: C503
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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