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	11/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2022, the customer processed the same sample five times.The results were not reproducible.On (b)(6) 2022, the complete arm of a mechanism was changed.On (b)(6) 2022, the customer processed 15 samples with reproducible results.On (b)(6) 2022, the customer sent samples for reprocessing to a reference laboratory that uses a cobas 6000.Similar results were obtained.On (b)(6) 2022, the fsr indicated that the results are now reproducible and that local maintenance has solved the issue.The investigation determined that the event was caused by a maintenance issue (exchange of mechanism).There was no indication of a reagent problem.H3 other text : na.
Event or Problem Description
The initial reporter received questionable a1cx3 (tina-quant hemoglobin a1cdx gen.3) results for four patient samples tested on a cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.On (b)(6) 2022: sample 1 the initial result was 17.4 %.The repeat result was 23.9 %.Sample 2 the initial result was 9.18 %.The repeat result was 7.5 %.Sample 3 the initial result was 7.01 %.The repeat result was 6.03 %.For sample 3, the reporter detected that the glucose result did not coincide with the hba1c result which prompted the rerun of the sample.On (b)(6) 2022, the field service representative (fsr) changed one of the solenoid valves (sv).On (b)(6) 2022, the following questionable results were obtained: sample 4 the initial result was 6.08 %.The repeat result was 7.1 %.Sample 5 the initial result was 7.02 %.The repeat result was 5.5 %.Sample 6 the initial result was 7.01 %.The repeat result was 6.03 %.Sample 7 the initial result was 8.03 %.The repeat result was 5.7 %.On (b)(6) 2022, the field service representative (fsr) changed the pipette and printed circuit board (pcb).He also adjusted the ultrasonic agitators as the frequencies did not match those of the agitator.The issue was not resolved.Sample 8 the initial result was 15.7 %.The repeat result was 7.16 %.The repeat results were deemed correct.  the reagent lot number was 62958201 with an expiration date of 31-aug-2023.
Additional Manufacturer Narrative
In mfr report ref #1823260-2023-00027-00, the first line of b5 - describe event or problem should have been: "the initial reporter received questionable a1cx3 (tina-quant hemoglobin a1cdx gen.3) results for eight patient samples tested on a cobas pro c 503 analytical unit." instead of: "the initial reporter received questionable a1cx3 (tina-quant hemoglobin a1cdx gen.3) results for four patient samples tested on a cobas pro c 503 analytical unit.".
Additional Manufacturer Narrative
Mdr codes component code and eval conclusion code were updated.

• 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: 16094840
• Report Number: 1823260-2023-00027
• Device Sequence Number: 20537241
• Product Code: JJE
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 03/07/2023

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: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 02/08/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/04/2023; 03/07/2023
• 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