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

Catalog Number	08057958190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00786
• Device Sequence Number: 1545975
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K964457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown