ORTHO BRAIN THROMBOPLASTIN 732470

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-13 for ORTHO BRAIN THROMBOPLASTIN 732470 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[119719] The customer reported that vials of obt348 are discolored and giving prolonged clotting times with level one control. If quality control testing is not properly performed prior to using a discolored vial of obt348 to test patient samples, erroneous pt clotting times and/or inr values may be reported. This corresponds to ortho-clinical diagnostics complaint number, 97-05270-10.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-1998-00091
MDR Report Key177293
Report Source05
Date Received1998-07-13
Date of Report1998-07-10
Date of Event1997-10-18
Date Mfgr Received1997-10-20
Device Manufacturer Date1997-04-01
Date Added to Maude1998-07-17
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 Location3
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameORTHO BRAIN THROMBOPLASTIN
Generic NamePROTHROMBIN TIME TEST
Product CodeGFO
Date Received1998-07-13
Model NumberNA
Catalog Number732470
Lot Number0BT348
ID NumberNA
Device Expiration Date2000-08-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key172397
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address1001 US HWY 202 RARITAN NJ 08869 US
Baseline Brand NameORTHO BRAIN THROMBOPLASTIN
Baseline Generic NamePROTHROMBIN TIME REAGENT
Baseline Model NoNA
Baseline Catalog No732470
Baseline IDPROTHROMBIN TIM
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-07-13

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