INTEGRA 800 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-26 for INTEGRA 800 * manufactured by Roche Diagnostics Corp..

Event Text Entries

[15806640] Erroneous hdl result of 81mg/dl reported at 18:52. Tech realized instrument malfunctioned. Instrument removed from service. Specimen was reanalyzed on alternate instrument. Hdl result corrected to 51mg/dl at 21:03. No patient harm and no change in patient's treatment plan. Manufacturer contacted and came on-site. Device returned to service the following day. ======================manufacturer response for lab analyzer, roche (per site reporter). ======================instrument removed from service. Manufacturer was contacted. Field service engineer replaced bad valve, ran system checks and performed quality control. All checks and qc were in acceptance range and instrument was put back into service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	4176241
MDR Report Key	4176241
Date Received	2014-09-26
Date of Report	2014-09-26
Date of Event	2014-09-17
Report Date	2014-09-26
Date Reported to FDA	2014-09-26
Date Reported to Mfgr	2014-10-16
Date Added to Maude	2014-10-16
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	INTEGRA 800
Generic Name	LAB ANALYZER
Product Code	CHH
Date Received	2014-09-26
Model Number	800
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	ROCHE DIAGNOSTICS CORP.
Manufacturer Address	9115 HAGUE RD INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-09-26