MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reaction monitor showed a very high initial absorbance for the initial result.The investigation assumed a pipetting error or a sample carryover.The calibration data provided from 24-sep-2022 to 05-jan-2023 was provided.The last calibration performed for the assay was within specifications.The non-roche qcs were within the +/- 2 standard deviation (sd) range on the date of the event.The roche qc1 was within the +/- 2 sd range, but no result was provided on the day of the event.The field service engineer (fse) inspected the module and noted the pressure of the old gear pump head to be 290 kpa.He replaced the gear pump head and the pressure was adjusted to 300 kpa.The fse verified the module's performance with 100 cycles of mechanism checks, qcs, and routine function tests with successful results.The investigation excluded a general reagent problem because the provided qc and calibration data were within specifications.The investigation determined that the issue was consistent with a single failed pipetting which did not occur again after the gear pump head was replaced.
Event or Problem Description
The initial reporter received a questionable altl alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation (altl) result from one patient sample tested on the cobas 6000 c501 module.The initial result was reported to the emergency department which requested verification.A rerun was performed on the reported module and their other c 501 module.The initial result from the module was 363.9 u/l.The first repeat result from the module was 17.8 u/l.The second repeat result from the other module was 18.1 u/l.The repeat result from the other module confirmed the result.The reagent lot number is 67320501.The expiration date is 31-jan-2024.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 16327237
• Report Number: 1823260-2023-00407
• Device Sequence Number: 18103891
• Product Code: JJE
• UDI-Device Identifier: 04015630913862
• UDI-Public: 04015630913862
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060373
• 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
• Report Date (Section B): 02/08/2023

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: C501
• Device Catalogue Number: 04745914001
• 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: 01/12/2023
• Initial Report FDA Received Date: 02/08/2023
• 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