MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACT GEN.2; LACTIC ACID TEST SYSTEM

Catalog Number	03183700190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable lact2 lactate gen.2 result for one patient sample with a cobas 8000 cobas c 502 module serial number unknown.The reporter stated that qc was out of range at the end of testing, they replaced the reagent pack and qc resumed to normal.All samples between the failed qc and most recent successful qc were repeated.The initial result was 2.62 mg/dl.The repeated result from a c503 was 1.83 mg/dl.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The customer's last calibration was inconspicuous.It was observed that the qc was within specification from (b)(6) 2021 until (b)(6) 2021 and jumps to above +3 sd on (b)(6) 2021.Afterward, the qc is within specification again.The investigation reviewed the system's alarm trace and no abnormalities were found.The investigation is ongoing.
Additional Manufacturer Narrative
A general system and reagent related issue can be excluded as in general the provided data for calibration and qc is within specification.The investigation determined the customer's actions of replacing the reagent resolved the issue.

• Brand Name: LACT GEN.2
• Common Device Name: LACTIC ACID 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: 13053761
• Report Number: 1823260-2021-03814
• Device Sequence Number: 1427844
• Product Code: KHP
• UDI-Device Identifier: 04015630918911
• UDI-Public: 04015630918911
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K964457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 03/11/2022

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: 09/30/2022
• Device Catalogue Number: 03183700190
• Device Lot Number: 57989201
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/11/2022
• 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
• Patient Sex: Unknown