ELECSYS CK-MB STAT IMMUNOASSAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for ELECSYS CK-MB STAT IMMUNOASSAY manufactured by Roche Diagnostics.

Event Text Entries

[134457258] 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 sample was requested for investigation but could not be provided. 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

[134457259] This report summarizes 1 malfunction event. High results were generated by the cobas 6000 e 601 module. The event involved a total of 1 patient with high results for the elecsys ck-mb stat immunoassay. The patient age was (b)(6). The patient weight was requested, but was not provided. The patient gender was female. 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: 1823260-2019-90066
• MDR Report Key: 8284597
• Date Received: 2019-01-29
• Date Added to Maude: 2019-01-29
• 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: 3

Device Details

• Brand Name: ELECSYS CK-MB STAT IMMUNOASSAY
• Generic Name: COLORIMETRIC METHOD, CPK OR ISOENZYMES
• Product Code: JHY
• Date Received: 2019-01-29
• Model Number: CK-MB STAT
• Lot Number: 297009
• 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		2019-01-29