ACCESS 2 IMMUNOASSAY SYSTEM 81600N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-24 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter.

Event Text Entries

[68387170] The customer did not provide patient demographics such as age, date of birth, or weight. (b)(6). A field service engineer (fse) was dispatched to the customer site. The fse replaced hardware parts to include replacement of the wash carousel bearings that were identified to have been damaged/deteriorated by spilled wash buffer. The damaged wash carousel bearings were causing rough movements of the reaction vessels (rvs) and rough movements of the wash carousel resulting in splashing of the reactants. There is sufficient evidence to determine a hardware malfunction as the cause of this event. (b)(4). All mdrs associated with this report are: 2122870-2017-00010, 2122870-2017-00011, 2122870-2017-00012, 2122870-2017-00015, 2122870-2017-00016, 2122870-2017-00017, 2122870-2017-00018, 2122870-2017-00019.
Patient Sequence No: 1, Text Type: N, H10


[68387171] The customer reported elevated dimeric inhibin a (access inhibin a) results had been generated for multiple patients on the customer's access2 immunoassay system (serial number (b)(4)). The customer received the latest report from their external quality assurance (eqa) program for antenatal screening and determined that they had reported an eqa access inhibin a survey result that was 5 times the instrument median. Upon receipt of this report, the customer repeated patient samples that were tested for access inhibin a who were reported as an increase risk. Repeat analysis of some the patient samples recovered with lower results, no longer in the increased risk category. Calibration data was not provided. System checks performed on (b)(4) 2017 failed to meet specifications with elevated % cv results. There were some instances of erratic access inhibin a quality control (qc) results generated around the time of this event. Patient sample collection and processing information was not provided. This report addresses the non-reproducible elevated access inhibin a result obtained for one patient (identified as patient 2) on (b)(6) 2016. Additional reports are as follows: 2122870-2017-00010 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for one patient. 2122870-2017-00011 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient. 2122870-2017-00012 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for three patients. 2122870-2017-00015 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for one patient. 2122870-2017-00016 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for one patient. 2122870-2017-00018 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient. 2122870-2017-00019 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2122870-2017-00017
MDR Report Key6357038
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-02-24
Date of Report2017-02-21
Date of Event2016-11-03
Date Mfgr Received2017-02-21
Device Manufacturer Date2008-08-15
Date Added to Maude2017-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANGELA KILIAN
Manufacturer Street1000 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal55318
Manufacturer Phone9523681330
Manufacturer G1BECKMAN COULTER
Manufacturer Street1000 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal Code55318
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCESS 2 IMMUNOASSAY SYSTEM
Generic NameANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
Product CodeNDR
Date Received2017-02-24
Model NumberNA
Catalog Number81600N
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.