DRIED POS MIC TYPE 20A B1017-203A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-20 for DRIED POS MIC TYPE 20A B1017-203A manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[17247742] Customer reported s aureus isolates oxacillin (ox) mic discrepancy. They obtained oxacillin-susceptible results on the dried pos mic type 20a panel and oxacillin-resistant results on secondary methods that were also performed for the clinical isolate. It is unk if the results were reported to the physician. No reports of adverse health consequences associated with the discrepant result being obtained. The cause of the oxacillin susceptible results is unk.
Patient Sequence No: 1, Text Type: D, B5


[17305675] Evaluation, method - routine monitoring of complaint history and performance trends to ensure performance is within claims. Evaluation results - requested additional information to determine if malfunction occurred. Evaluation conclusions - product is within performance claims. The cause of the oxacillin susceptible results is unk.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2008-00004
MDR Report Key1002087
Report Source05
Date Received2008-02-20
Date of Report2008-02-12
Date of Event2008-01-30
Date Mfgr Received2008-01-30
Device Manufacturer Date2007-11-01
Date Added to Maude2008-05-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactRICH LAGUNA
Manufacturer Street2040 ENTERPRISE BLVD.
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163743163
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRIED POS MIC TYPE 20A
Generic NameANTIMICROBIC SUSCEPT. PANEL: GRAM POS
Product CodeLTT
Date Received2008-02-20
Model NumberNA
Catalog NumberB1017-203A
Lot Number2008-11-19
ID NumberNA
Device Expiration Date2008-11-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key999310
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-02-20

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