MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LI; LITHIUM TEST SYSTEM

Model Number	LITHIUM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable li lithium results for one patient sample with a cobas 6000 c 501 module.The initial result was 1.62 mmol/l.The repeated result was 1.61 mmol/l.The clinician questioned the result as it did not match the patient¿s condition so the sample was sent to another laboratory for testing.The result from the other laboratory using an unknown method was 0.6 mmol/l.The reagent lot number was 542029.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Section d4, expiration date was updated.The c501 module serial number was (b)(6).The patient sample was submitted for investigation.The sample was on a c501 module and the results were 0.57 mmol/l, 0.59 mmol/l and 0.58 mmol/l.The customer's high lithium results could not be reproduced.The sample was further investigated on an an integra 400 plus where the customer's high lithium results were confirmed.The sample was tested 4 times and the mean result was 2.58 mmol/l.Clarification is currently not possible with available information and measured results.No reagent specific issue could be identified, reagent meets specification.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: LI
• Common Device Name: LITHIUM TEST SYSTEM
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13119011
• Report Number: 1823260-2021-03943
• Device Sequence Number: 11274030
• Product Code: JIX
• UDI-Device Identifier: 04015630921669
• UDI-Public: 04015630921669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 02/28/2023
• Device Model Number: LITHIUM
• Device Catalogue Number: 04679598190
• Device Lot Number: 542029
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 04/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARBEMAZOL; DULOXETIN; LITHIUM; METFORMIN; PIPANTERON; RISPERIDON; TAMSOLOSIN
• Patient Sex: Unknown