ABBOTT LCX CT NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-14 for ABBOTT LCX CT NI manufactured by *.

Event Text Entries

[15035279] Rptr had problems late in 2000 with the lcx gonorrhea assay. Rptr then searched and found: "reproducibility problems with the abbott lab lcx assay for chlamydia trachomatis and neisseria gonorrhoeae" by ann m gronowski, susan copper, david baorto, and patrick r murray (dept of pathology, div of laboratory medicine, washington univ school of medicine, and barnes-jewish hosp, st louis, missouri 63110). Journal of clinical microbiology, june 2000, p 2416-2418, vol 38, no 6. Abstract: this study demonstrates that significant reproducibility problems can occur during routine use of the abbott laboratories lcx assay for chlamydia trachomatis and neisseria gonorrhoeae. These problems can go undetected by the quality control procedure outlined in the mfr's package insert. Rptr outlines here procedures for detecting and preventing contamination and reproducibility problems. Rptr is already doing many of their suggestions but not using the extended grey zone. Rptr started using the extended grey zone and implemented the remainder of their suggestions and no longer have a problem with either assay. Of note is that when rptr telephoned abbott and cited this article, no one rptr found at abbott seemed to know about the article despite the statement in the article that "after repeated discussions with abbott lab and other labs performing the lcx assay, it became clear that these types of problems are not uncommon. Rptr concluded that reproducibility problems originated primarily in the sample processing area. Based on suggestions from abbott labs and other lcx users, the microbiology lab underwent numerous changes in its specimen processing and has incorporated procedures that are not listed in the lcx package insert. " as of when rptr last checked, there are still no changes in the package insert and rptr is unaware that abbott has called this article to the attention of users.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1021207
MDR Report Key318049
Date Received2001-02-14
Date of Report2001-02-14
Date of Event2000-01-01
Date Added to Maude2001-03-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameABBOTT LCX CT
Generic Name*
Product CodeJSX
Date Received2001-02-14
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
Device Availability*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key307566
Manufacturer*
Manufacturer Address* * *

Device Sequence Number: 2

Brand NameABBOTT LCX CT
Generic Name*
Product CodeLJC
Date Received2001-02-14
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
Device Availability*
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No2
Device Event Key307567
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2001-02-14

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