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

Model Number	LITHIUM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that the calibration results were inconspicuous and the qc results were acceptable, a general reagent or instrument issue can be excluded.The sample was submitted for investigation and the customer's results could be confirmed.The follow up/corrective actions were not provided.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Erroneous low results were generated by the cobas 6000 c (501) module.The event involved 1 patient with erroneous results for li lithium that did not correlate with the patient's treatment.The patient's age was (b)(6).The patient's gender was male.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.
Additional Manufacturer Narrative
The patient sample was submitted for investigation and tested using the icp-oes (inductively coupled plasma-optical emission spectroscopy) test method.The customer's results were confirmed to be correct as the sample was negative for lithium.There was no malfunction of the device.

• Brand Name: LI LITHIUM
• Common Device Name: LITHIUM TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8278635
• Report Number: 1823260-2019-90020
• Device Sequence Number: 1598486
• Product Code: NDW
• UDI-Device Identifier: 04015630921669
• UDI-Public: 04015630921669
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: LITHIUM
• Device Lot Number: 29913401
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1