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.
[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
Report Number | 9612296-2016-00095 |
MDR Report Key | 5840948 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2016-08-02 |
Date of Report | 2016-07-13 |
Date of Event | 2016-07-09 |
Date Mfgr Received | 2016-07-13 |
Device Manufacturer Date | 2014-10-01 |
Date Added to Maude | 2016-08-02 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 0 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. DAVID DAVIS |
Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
Manufacturer City | BREA CA 928218000 |
Manufacturer Country | US |
Manufacturer Postal | 928218000 |
Manufacturer Phone | 7149613796 |
Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
Manufacturer Street | 454-32 HIGASHINO, NAGAIZUMI-CHO SUNTO-GUN |
Manufacturer City | SCHIZUOKA, MISHIMA, JP-NOTA 41 |
Manufacturer Country | JA |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AU680 CLINICAL CHEMISTRY ANALYZER |
Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
Product Code | MGX |
Date Received | 2016-08-02 |
Model Number | AU681-10E |
Catalog Number | B12188 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 0 |
Device Event Key | 0 |
Manufacturer | BECKMAN COULTER, INC |
Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2016-08-02 |