MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS LITHIUM; LITHIUM ASSAY

Catalog Number	08057974190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable lithium result from the cobas c 503 analytical unit.The initial result was 0.1 mmol/l with a data flag and was reported outside of the laboratory.The result did not match the patient's history and the sample was repeated.The repeat result was 2.3 mmol/l and was believed to be correct.
Additional Manufacturer Narrative
Medwatch fields a2, a3, a4, b7, and d10 were updated.
Additional Manufacturer Narrative
The field service engineer checked the analyzer and did not find a cause.As the customer was unable to provide further information, a definite root cause analysis was not possible.The investigation did not identify a product problem.The issue was consistent with a pre-analytical handling issue at the customer site.The customer was using a shorter centrifugation time than what is typically recommended by tube manufacturers.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• Brand Name: COBAS LITHIUM
• Common Device Name: LITHIUM ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18933199
• Report Number: 1823260-2024-00811
• Device Sequence Number: 4512985
• Product Code: NDW
• UDI-Device Identifier: 07613336121382
• UDI-Public: 07613336121382
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K063684
• 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,Followup,Followup
• Report Date (Section B): 03/11/2025

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: 08057974190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 03/11/2025
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/16/2024; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALPRAZOLAM (XANAX); ESTRADIOL (ESTRACE); QUETIAPINE FUMARATE (SEROQUEL); SYNTHROID
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 59 KG