DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT B4218-1

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 2015-04-09 for DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT B4218-1 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[5609525] The customer experienced biased high qc recoveries for activated partial prothrombin time (aptt) with actin reagent. It is unknown if patient results were reported to physicians while the lot was in evaluation.. It is unknown if patient treatment or diagnosis was altered on the basis of the biased high aptt results. There was no report of adverse health consequences as a result of the biased high aptt results.
Patient Sequence No: 1, Text Type: D, B5


[13276286] Siemens healthcare diagnostics has confirmed internally that for a group of affected actin lots including lot 557134, the recovery of controls can be found outside the assigned ranges. Furthermore, a drift in the normal range towards higher results has been observed. This indicates a change of the product performance over the shelf life. Siemens has confirmed a drift greater than 3 seconds in the normal aptt range and / or greater than 15 % in the pathological range over the shelf-life. It is possible that patients with values close to the medical decision points could exhibit a deviation of up to 4 seconds for the normal range and up to 33% for the pathological range. The described drift towards higher aptt values will be recognized in most cases by control recovery out of the assigned range. Siemens issued an urgent medical device recall communication br-01315 dated march 2015 to customers who had ordered the affected lots advising them to discontinue the use of the lots. Siemens offered a no charge replacement with a non-impacted lot.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610806-2015-00010
MDR Report Key4672005
Report Source05,06
Date Received2015-04-09
Date of Report2015-03-10
Date of Event2014-12-18
Date Mfgr Received2015-03-10
Device Manufacturer Date2013-12-11
Date Added to Maude2015-05-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationSERVICE PERSONNEL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer Street76 EMIL VON BEHRING STRASSE
Manufacturer CityMARBURG, 35041
Manufacturer CountryGM
Manufacturer Postal Code35041
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number9610806-03-24-2015-002-C
Event Type3
Type of Report3

Device Details

Brand NameDATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT
Generic NameDATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT
Product CodeGFO
Date Received2015-04-09
Catalog NumberB4218-1
Lot Number557134
Device Expiration Date2015-11-21
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer Address76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-09

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