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

Catalog Number 08057958190

Device Problems Chemical Problem (2893); Non Reproducible Results (4029)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with ldhi2 on a cobas c 503 analytical unit.The sample initially resulted in an ldh value of 602 u/l.The sample was repeated, resulting in a value of 350 u/l.The sample was also repeated on a second analyzer, resulting in an ldh value of 394 u/l.

Manufacturer Narrative

The serial number of the c503 analyzer is(b)(6).The investigation is ongoing.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The customer stated using the pre-dilution application of the ldh test and this has been working fine for the customer.No further issues were encountered.

• 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): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18949649
• MDR Text Key: 338444315
• Report Number: 1823260-2024-00846
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 04/19/2024

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: 08057958190
• Device Lot Number: 712166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• 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