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	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable a1c-2 tina-quant hemoglobin a1c gen.3 results for an unknown number of patients' samples tested on a cobas pro c 503 analytical unit when compared to previous measurements.It was alleged that the results made healthy patients appear to be pre-diabetic and pre-diabetic patients appear to be diabetic.The patients' discrepant result information was requested but not provided at this time.The reagent lot number is 64510301.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The alarm log shows frequent abnormal aspiration alarms.It was found that the humidity in the customer's lab is lower than 20%.The specifications of the system indicate that humidity levels lower than 30% can affect sample and qc material due to evaporation on the sample surface and cause result deviations.The investigation also found that the qc values dropped without changes in calibration, indicating the prolonged use of qc material.The instrument is performing within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
Ten samples were provided for investigation.The investigation could not confirm the customer's discrepant result differences.It was found that the customer was comparing the c503 hba1c results to the corresponding patients' previous c501 hba1c results.Method comparison measurements should be performed according to a standardized procedure to be valid.The customer's c503 module was confirmed to be running within the manufacturer's specifications.Comparison measurements of the samples' results compared to investigational measurement results confirmed the acceptable performance of the assay.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: 16283495
• Report Number: 1823260-2023-00319
• Device Sequence Number: 17839006
• Product Code: JJE
• UDI-Device Identifier: 07613336157824
• UDI-Public: 07613336157824
• 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,Followup
• Report Date (Section B): 06/01/2023

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
• Device Lot Number: 64510301
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 01/31/2023; 05/04/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/28/2023; 06/01/2023
• 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