MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDHI2; LACTATE DEHYDROGENASE TEST SYSTEM

Catalog Number ASKU

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable ldhi2 lactate dehydrogenase acc.To ifcc ver.2 and tpuc3 total protein urine/csf gen.3 results for 1 patient cerebrospinal fluid (csf) sample on a cobas 8000 cobas c 701 module.This medwatch will cover ldhi2.Refer to medwatch with a1 patient identifier (b)(6) for information on the tpuc3 results.The initial ldh result was 2 u/l.The repeat ldh result was 202 u/l.

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: LDHI2
• Type of Device: LACTATE DEHYDROGENASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18310688
• MDR Text Key: 330282443
• Report Number: 1823260-2023-03951
• Device Sequence Number: 1
• Product Code: CFJ
• Combination Product (y/n): Y
• Reporter Country Code: LU
• PMA/PMN Number: K100853
• 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: 01/29/2024
• 2 Devices were Involved in the Event: 1 2

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1