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

Catalog Number	08057974190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with li lithium on a cobas pro c 503 analytical unit serial number (b)(4).The initial values were reported outside of the laboratory.Due to previous issues, the samples were repeated on a second analyzer on 03-feb-2023 and these values were deemed correct.The first sample initially resulted in a lithium value of 1.2 mmol/l and repeated as 0.7 mmol/l.The second sample initially resulted in a lithium value of 1.9 mmol/l and repeated as 0.6 mmol/l.
Additional Manufacturer Narrative
The last calibration performed on 29-jan-2023 was within specifications.The qc recovery was within -2 standard deviations (sd).There is no indication of a performance issue with the reagent.The field applications specialist (fas) inspected the analyzer and found that the issue was due to interference with the hdl assay.The customer worked with fas to configure an extra wash cycle.They performed operational tests and qc with acceptable results.After this intervention, no further issues were reported by the customer.  product labeling states "to avoid carryover between tests, the system can perform special washes.Download all required special washes ( manufacturer rules).You can program additional special washes manually ( user rules)." the investigation determined the service actions resolved the issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16456723
• Report Number: 1823260-2023-00621
• Device Sequence Number: 6515063
• Product Code: NDW
• UDI-Device Identifier: 07613336121382
• UDI-Public: 07613336121382
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/03/2023

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 08057974190
• Device Lot Number: 59094201
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/03/2023
• 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: 50 YR
• Patient Sex: Female