AU680 CLINICAL CHEMISTRY ANALYZER AU681-10E B12188

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-08-02 for AU680 CLINICAL CHEMISTRY ANALYZER AU681-10E B12188 manufactured by Beckman Coulter, Inc.

Event Text Entries

[50958640] A beckman field service engineer (fse) was dispatched and evaluated the system. The fse identified no malfunction or deficiency with the system. All probes, mixers, and wash station alignments were verified. All fluidics and wash station operations were verified. All syringes and wash pump operations were verified. Fse performed n=20 precision study with positive control material for all 4 assays and results met performance specifications. There was no reagent malfunction noted as all calibrations and controls had been passing and acceptable. Evaluation of reaction monitor data printed from the instrument demonstrated that false negative drug results were due to no sample addition in the reaction cuvette. No other sample was reported to have been affected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[50958641] On (b)(6) 2016: a (b)(6) male was found in bed unresponsive and "twitching" by emergency medical services (ems) and was brought by ambulance to the emergency room (er). Information provided at the scene included use of marijuana (thc) but no clear medical history and no known taken medications could be provided. Ems administered narcan at the scene and transport the patient. In the er, patient presented with low blood pressure and was unresponsive. Er doctor ordered laboratory tests and urine drug screen. The customer reported obtaining non-reproducible negative results for amphetamine (amph), benzodiazepine (benz), opiate (op), and cannabinoid (thc) on urine drug screen. The results were generated by the au680 clinical chemistry analyzer for one patient. Erroneous results were reported out of the laboratory to the emergency room (er). With the drug screen results negative, er doctors performed a lumbar puncture on the patient trying to determine why the patient was unresponsive. Customer indicated there were no result flags to indicate any issues. A second drug screen was ordered and results were positive for amph, benz, op, and thc. Amended results were issued. Calibration and quality controls (qc) were performing within assay and instrument specifications. No hardware errors, flags or other assay issues were reported in conjunction with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612296-2016-00095
MDR Report Key5840948
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-08-02
Date of Report2016-07-13
Date of Event2016-07-09
Date Mfgr Received2016-07-13
Device Manufacturer Date2014-10-01
Date Added to Maude2016-08-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DAVID DAVIS
Manufacturer Street250 S. KRAEMER BLVD. M/S E1.SE.01
Manufacturer CityBREA CA 928218000
Manufacturer CountryUS
Manufacturer Postal928218000
Manufacturer Phone7149613796
Manufacturer G1BECKMAN COULTER MISHIMA K.K.
Manufacturer Street454-32 HIGASHINO, NAGAIZUMI-CHO SUNTO-GUN
Manufacturer CitySCHIZUOKA, MISHIMA, JP-NOTA 41
Manufacturer CountryJA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameAU680 CLINICAL CHEMISTRY ANALYZER
Generic NameANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Product CodeMGX
Date Received2016-08-02
Model NumberAU681-10E
Catalog NumberB12188
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerBECKMAN COULTER, INC
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-08-02

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