IMX ANALYZER 8389-59

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-10-09 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing, Inc..

Event Text Entries

[266973] A physician questioned an initial imx bhcg assasy result of 914 mlu/ml. The patient (possible ectopic pregnancy) was redrawn and tested two days later and generated a result of 5580. 10 mlu/ml. An ultrasound was performed and confirmed a viable pregnancy. The initial sample was retested and generated a result of 3124 mlu/ml. All controls were within specifications on all runs. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-2002-00055
MDR Report Key422335
Report Source06
Date Received2002-10-09
Date of Report2002-10-09
Date of Event2002-09-23
Date Mfgr Received2002-09-25
Device Manufacturer Date2001-12-01
Date Added to Maude2002-10-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Manufacturer ContactPAUL LANDESMAN
Manufacturer Street100 ABBOTT PARK ROAD D-09D5, AP6C-6
Manufacturer CityABBOTT PARK IL 600643500
Manufacturer CountryUS
Manufacturer Postal600643500
Manufacturer Phone8479372688
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMX ANALYZER
Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Product CodeLCI
Date Received2002-10-09
Model NumberNA
Catalog Number8389-59
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key411391
ManufacturerABBOTT MANUFACTURING, INC.
Manufacturer Address1921 HURD DR IRVING TX 75038 US
Baseline Brand NameIMX ANALYZER(REFURB)
Baseline Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Baseline Model NoNA
Baseline Catalog No8389-59
Baseline IDNA
Baseline Device FamilyIMX
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK864319
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2002-10-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.