DRIED POS COMBO TYPE 20 B1017-200

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 2008-01-10 for DRIED POS COMBO TYPE 20 B1017-200 manufactured by Siemens Healthcare Diagnostics Inc.,.

Event Text Entries

[17484587] Customer reported s. Aureus isolate oxacillin (ox) mic discrepancy. They obtained oxacillin-susceptible results on the dried pos combo type 20 panel and oxacillin-resistant results on secondary methods that were also performed for the clinical isolate. Results were not 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 unknown.
Patient Sequence No: 1, Text Type: D, B5


[17542728] Evaluation: 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 unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2008-00001
MDR Report Key977955
Report Source05
Date Received2008-01-10
Date of Report2007-01-02
Date of Event2007-12-14
Date Mfgr Received2007-12-14
Device Manufacturer Date2006-11-01
Date Added to Maude2008-11-07
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
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDRIED POS COMBO TYPE 20
Generic NameANTIMICROBIC SUSCEPT. PANEL: GRAM POS
Product CodeLTT
Date Received2008-01-10
Model NumberNA
Catalog NumberB1017-200
Lot Number2008-10-08
ID NumberNA
Device Expiration Date2008-10-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key980201
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.,
Manufacturer Address2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-01-10

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