DADE ACTIN FS ACTIVATED PTT REAGENT B4218-100

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 2005-10-14 for DADE ACTIN FS ACTIVATED PTT REAGENT B4218-100 manufactured by Dade Behring Gmbh.

Event Text Entries

[442659] A customer obtained erroneously high controls with actin fs lot 527263. Erroneously prolonged aptt test results have been observed with abnormal citrol controls and patient samples. There were no adverse health consequences to the patient; treatment was not perscribed or altered based on the erroneously high controls. (note: customer unable to provide date of event).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2005-00025
MDR Report Key695909
Report Source05
Date Received2005-10-14
Date of Report2005-10-14
Date Mfgr Received2005-09-23
Device Manufacturer Date2005-07-01
Date Added to Maude2006-04-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactAYDEE CRAWFORD
Manufacturer StreetP.O. BOX 6101 M/S 514
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026316312
Manufacturer G1DADE MARBURG GMBH
Manufacturer Street76 EMIL VON BEHRING STRASSE
Manufacturer CityMARBURG
Manufacturer CountryGM
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number9610806-10/07/05-001-C
Event Type3
Type of Report3

Device Details

Brand NameDADE ACTIN FS ACTIVATED PTT REAGENT
Generic NameACTIVATED PARTIAL THROMBOPLASTIN TIME
Product CodeGIT
Date Received2005-10-14
Model NumberNA
Catalog NumberB4218-100
Lot Number527263
ID NumberNA
Device Expiration Date2006-02-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key685017
ManufacturerDADE BEHRING GMBH
Manufacturer Address* MARBURG GM
Baseline Brand NameDADE ACTIN FS ACTIVATED PTT REAGENT
Baseline Generic NameACTIVATED PARTIAL THROMBOPLASTIN TIME
Baseline Model NoNA
Baseline Catalog NoB4218-100
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2005-10-14

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