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

Model Number	C503
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gluc3 glucose hk gen.3 results for 3 patient samples on a cobas pro c 503 analytical unit.For sample 1, the initial glucose result was 6.74 g/l.The repeat result was 4.46 g/l.For sample 2, the initial glucose result was 8.51 g/l.The sample was repeated 5 times and the results were 4.06 g/l, 4.07 g/l, 4.05 g/l, 4.03 g/l, and 4.04 g/l.For sample 3, the initial glucose result was 10.1 g/l.The repeat result was 5.1 g/l.The repeat results were deemed correct.Clarification on whether the initial results were reported outside of the laboratory was requested but not provided.The reagent lot number is 64350301 and the expiration date is 31-aug-2023.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 16486580
• Report Number: 1823260-2023-00664
• Device Sequence Number: 15143288
• Product Code: JJE
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K191899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/01/2023

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: 02/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/01/2023
• 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