UNICEL? DXC 880I SYNCHRON ? ACCESS CLINICAL SYSTEM A59102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-12-11 for UNICEL? DXC 880I SYNCHRON ? ACCESS CLINICAL SYSTEM A59102 manufactured by Beckman Coulter.

Event Text Entries

[3960230] The customer reported obtaining false high potassium (k) results for fourteen (14) patient samples from the unicel dxc 880i synchron access clinical system. The customer reported the results out of the laboratory and one (1) patient was treated based upon a false high k result. This report references the other thirteen (13) patients involved in this event; please refer to medwatch report #2050012-2013-00813 for the report of the patient who was treated. The customer repeated the samples on an alternate analyzer and issued amended reports. There was no change or affect to treatment for the thirteen patients referenced in this report. Quality control (qc) results prior to the event exhibited imprecision. Potassium qc prior to the event recovered 8. 7 mmol/l and repeated at 7. 5 mmol/l (mean was 7. 5 mmol/l). Patient samples were then run and k qc following the sample run recovered at 9. 3 and 8. 4 mmol/l. The customer recalibrated the instrument and k qc recovered at 7. 4 and 7. 6 mmol/l. The customer then ran patient samples again. A review of the customer's instrument data log indicated that the system had multiple calibration failures starting on (b)(6) 2013 through the day of the event. In addition to the erratic qc and calibration failures, on the day of the event, the instrument also flagged intermittent k results with a "sample reference drift" flag.
Patient Sequence No: 1, Text Type: D, B5


[11379052] (b)(6). A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse evaluated the instrument and discovered a crack in the flowcell, adjacent to the potassium (k) electrode port. The fse proceeded to replace the flowcell to resolve the issue. Although it is unknown how the flowcell became cracked, the instrument provided multiple indications of the issue, with calibration failures, quality control (qc) failures, and flagged results. The customer continued to report patient results despite these indicators. Results: flowcell.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2013-00812
MDR Report Key3516269
Report Source01,05,06
Date Received2013-12-11
Date of Report2013-11-22
Date of Event2013-11-22
Date Mfgr Received2013-11-22
Device Manufacturer Date2006-12-14
Date Added to Maude2014-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. DUNG NGUYEN
Manufacturer Street250 S. KRAEMER BOULEVARD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149614941
Manufacturer G1BECKMAN COULTER
Manufacturer Street250 S. KRAEMER BLVD.
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal Code92821
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNICEL? DXC 880I SYNCHRON ? ACCESS CLINICAL SYSTEM
Generic NameANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Product CodeMZV
Date Received2013-12-11
Model NumberNA
Catalog NumberA59102
Lot NumberNA
ID NumberSW VERSION 4.92
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2013-12-11

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