ARCHITECT C8000 SYSTEM 01G06-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-10-07 for ARCHITECT C8000 SYSTEM 01G06-01 manufactured by Abbott Manufacturing Inc.

Event Text Entries

[3753347] The customer reports a falsely elevated potassium assay result generated for one patient sample on the architect c8000 analyzer. An initial result of 7. 1 mmol/l was generated and not reported from the lab. The sample retested at 4. 7, 4. 7 and 4. 8 mmol/l. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


[11263185] An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1628664-2013-00277
MDR Report Key3391078
Report Source01,05
Date Received2013-10-07
Date of Report2013-09-25
Date Mfgr Received2013-09-25
Date Added to Maude2013-12-24
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 ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone847937-512
Manufacturer G1ABBOTT LABORATORIES
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 60064350
Manufacturer CountryUS
Manufacturer Postal Code60064 3500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT C8000 SYSTEM
Product CodeMZV
Date Received2013-10-07
Catalog Number01G06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2013-10-07

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