MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05641489001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hdlc4 reagent lot number was 67451701 with an expiration date of 30-sep-2024.The gluc reagent lot number was 67427101 with an expiration date of 31-jan-2024.The last gluc calibration was performed on (b)(6) 2023 and it was ok with no alarms.The last hdl calibration was performed on (b)(6) 2023 and it was ok with no alarms.Qc recovery before the event was verbally provided by the customer and it was acceptable.The alarm trace did not show any abnormalities.The field service engineer (fse) found that the sample probe at the reaction cells was misaligned.He realigned the sample probe.The customer performed qc and it was acceptable.The fse did a performance check and the instrument was performing within specifications.The service actions (realigning the sample probe) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with hdl-cholesterol gen.4 (hdlc4) assay and 2 patients' serum samples tested with glucose hk gen.3 (gluc3) assay on a cobas 8000 cobas c701 analyzer.Sample 1 (patient 1) was tested for hdlc4: initial result: 0 mg/dl.Repeat result: 59 mg/dl.Sample 2 (patient 2) was tested for gluc3: initial result: 0 mg/dl.Repeat result: 89 mg/dl.Sample 3 (patient 3) was tested for gluc3: initial result: 0 mg/dl.Repeat result: 110 mg/dl.No questionable results were reported outside the laboratory.The zero results prompted the repeat of the samples.The repeat results were deemed to be correct.

• Brand Name: COBAS 8000 C 701 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18317274
• Report Number: 1823260-2023-03967
• Device Sequence Number: 6278766
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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 Catalogue Number: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/13/2023
• 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 Age: 48 YR
• Patient Sex: Male