TDXFLX SYSTEM 4A24-96

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-11 for TDXFLX SYSTEM 4A24-96 manufactured by Abbott Mfg., Inc..

Event Text Entries

[121015] On or around 8/14/98, an error code "sample level hi" was printed on the data tape when an amniotic fluid sample was initially tested for tdxflx flm ii. The operator reported the result as "hi. " the initial testing was performed on a fresh sample. The sample was retested giving a result of 16. 0 mg/g. The retest was performed on a frozen sample. According to the account, the mother went into labor and the clinician was unable to stop it. No further info has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-1998-00081
MDR Report Key187244
Report Source05,06
Date Received1998-09-11
Date of Report1998-09-10
Date of Event1998-08-14
Date Mfgr Received1998-08-14
Device Manufacturer Date1991-05-01
Date Added to Maude1998-09-16
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTDXFLX SYSTEM
Generic NameAUTOMATED FPIA ANALYZER
Product CodeLCQ
Date Received1998-09-11
Model NumberNA
Catalog Number4A24-96
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key182010
ManufacturerABBOTT MFG., INC.
Manufacturer Address1921 HURD DR. IRVING TX 75038 US
Baseline Brand NameTDXFLX FPIA ANALYZER - REBURB
Baseline Generic NameAUTOMATED FPIA ANALYZER
Baseline Model NoNA
Baseline Catalog No4A24-96
Baseline IDNA
Baseline Device FamilyTDX AND TDXFLX SYSTEMS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK904226
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-09-11

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