MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2; LACTATE DEHYDROGENASE TEST SYSTEM

Model Number LDHI G2

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The follow up/corrective actions were that the customer changed the reagent cassette and the issue seems to be resolved as there have been no further issues.Precision check testing was performed with acceptable results.No devices were returned this device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.An erroneous low result was generated by the cobas 8000 c 702 module.The event involved 1 patient with an erroneous result for ldhi2 lactate dehydrogenase acc.To ifcc ver.2.The patient's age was requested but was not provided.The patient's weight was requested but was not provided.The patient's gender was requested but was not provided.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

• Brand Name: LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2
• Type of Device: LACTATE DEHYDROGENASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8281628
• MDR Text Key: 134469708
• Report Number: 1823260-2019-90010
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 04015630925056
• UDI-Public: 04015630925056
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Model Number: LDHI G2
• Device Lot Number: 36247301
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1