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

Catalog Number 03183700190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 284189666
• Report Number: 1823260-2021-03814
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 04015630918911
• UDI-Public: 04015630918911
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K964457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1