ORTHO SUMMIT PROCESSOR 7003015 936480

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-21 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[264770] During a review of the ocd complaint system, this incident was deemed to be similar in nature to recently reported events concerning negative ods on the ortho summit processor. The customer reported that after pipetting an hbsag microwell plate on osp, negative ods were reported in some of the rows of the microwell plate. No error was reported. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-2003-00668
MDR Report Key450309
Date Received2003-03-21
Date of Report2003-03-18
Date of Event2002-04-01
Date Facility Aware2002-04-01
Report Date2003-03-18
Date Reported to Mfgr2002-04-01
Date Added to Maude2003-03-28
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHO SUMMIT PROCESSOR
Generic NameSAMPLE PROCESSOR
Product CodeJTL
Date Received2003-03-21
Model Number7003015
Catalog Number936480
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age4 YR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key439308
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address1001 US HWY 202 RARITAN NJ 088690606 US
Baseline Brand NameORTHO SUMMIT PROCESSOR
Baseline Generic NameSAMPLE PROCESSOR
Baseline Model No7003015
Baseline Catalog No936480
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-03-21

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