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

Catalog Number 08057958190

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

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

There was an allegation of a questionable low ldhi2 lactate dehydrogenase ver.2 result from cobas pro c 503 analytical unit serial number (b)(4).The initial result was 167 u/l.The repeat result at another site was 409 u/l.On (b)(6) 2022, the repeat result using reagent lot number 618368 was 399 u/l.Using a new pack from reagent lot 589772, the result was 409 u/l.It was requested but not known if any questionable result was reported outside of the laboratory.The repeat results were believed to be correct.

Manufacturer Narrative

The calibration data provided was acceptable.The issue was resolved by the customer using a new reagent cassette from the same lot.The investigation determined the issue was consistent with contamination or denaturation of a single reagent cassette.The cause of the contamination or denaturation could not be determined with the information available.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13838949
• MDR Text Key: 287602369
• Report Number: 1823260-2022-00786
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K964457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 08057958190
• Device Lot Number: 58977201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/21/2022
• 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