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

Catalog Number	07005717190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with low density lipoproteins-cholesterol gen.3 (ldl3) assay and 1 patient's sample tested with trigylcerides (trigl) assay on a cobas 6000 c501 analyzer.Sample 1 was tested for ldl3 (patient 1): initial result: 54 mg/dl.Rerun result: 137.7 mg/dl.No questionable result was reported outside the laboratory as the result did not match the patient's history.The sample was then repeated and the repeat result was deemed to be correct.Sample 2 was tested for trigl (patient 2): initial result: 366.9 mg/dl.1st repeat result: 265.5 mg/dl.2nd repeat result: 266 mg/dl.
Additional Manufacturer Narrative
The ldl3 reagent lot numbers provided were 56497800 and 59539300.The expiration dates were not provided.The trigl reagent lot number and expiration date were not provided.The gear pump pressure was 300 kpa.The investigation is ongoing.
Additional Manufacturer Narrative
The medical device problem code was updated.Calibration data was provided for ldl3.Calibration was last performed on (b)(6)-2023 and was acceptable.Qc was acceptable."abnormal aspiration" and "sample short" alarms were observed in the alarm trace data.Instrument check results were acceptable.A hardware check was performed where issues were noted.Various parts were replaced and adjustments were made.Following these actions, the hardware check was acceptable and the customer has had no further issues.A general reagent issue was excluded as calibration and qc were acceptable.As the service actions resolved the issue, the investigation determined the event was due to a hardware/maintenance issue.

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17850833
• Report Number: 1823260-2023-03147
• Device Sequence Number: 14291035
• Product Code: JJE
• UDI-Device Identifier: 04015630934584
• UDI-Public: 04015630934584
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K012287
• 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
• Report Date (Section B): 10/12/2023

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: 07005717190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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: 42 YR
• Patient Sex: Female