LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 LDHI G2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 LDHI G2 manufactured by Roche Diagnostics.

Event Text Entries

[134469708] 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.
Patient Sequence No: 1, Text Type: N, H10

[134469709] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2019-90010
• MDR Report Key: 8281628
• Date Received: 2019-01-28
• Date Added to Maude: 2019-01-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD NA
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175214343
• Manufacturer G1: ROCHE DIAGNOSTICS GMBH
• Manufacturer Street: SANDHOFFERSTRASSE 116 NA
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG), NA 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2
• Generic Name: LACTATE DEHYDROGENASE TEST SYSTEM
• Product Code: CFJ
• Date Received: 2019-01-28
• Model Number: LDHI G2
• Lot Number: 36247301
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-28