MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACTATE DEHYDROGENASE; LACTATE DEHYDROGENASE ASSAY USING NAD/NADH

Catalog Number 03004732122

Device Problem Non Reproducible Results (4029)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

The provided calibration and control data were acceptable.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with ldhi2 lactate dehydrogenase acc.To ifcc ver.2 on a cobas integra 400 plus (serial number (b)(4).No questionable results were reported outside of the laboratory.The customer initially had issues with an unspecified number of patient samples tested with ldh.The results would be high and then repeat lower.The probes were replaced and precision was checked.A wash station was also inspected.The field application specialist updated the application settings to use a different application of the same reagent, but the issue still persisted leading to the complained sample results.The sample initially resulted in an ldh value of 733 u/l.Due to ongoing issues of the same nature, the sample was repeated twice, resulting in values of 211 u/l and 217 u/l.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: LACTATE DEHYDROGENASE
• Type of Device: LACTATE DEHYDROGENASE ASSAY USING NAD/NADH
• 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: 16531778
• MDR Text Key: 311573614
• Report Number: 1823260-2023-00790
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 04015630916276
• UDI-Public: 04015630916276
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 03004732122
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/10/2023
• 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