DRIED POS COMBO TYPE 21 B1017-201

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 2006-11-15 for DRIED POS COMBO TYPE 21 B1017-201 manufactured by Dade Behring, Inc..

Event Text Entries

[572871] Single account reported to dade behring that they observed a clinical s. Aureus isolate oxacillin (ox) mic discrepancy. The account obtained oxacillin susceptible results on the dried pos combo type 21 panel and oxacillin-resistant results on secondary methods that were also performed for the clinical isolate. Account correctly reported isolate as resistant to the physician based on the result of alternate methods. No report of injuries associated with the susceptible result being obtained.
Patient Sequence No: 1, Text Type: D, B5


[7914885] Evaluation method: contacted customer to obtain clinical isolate for evaluation. Routine monitoring of complaint history and performance trends to ensure performance is within claims. Evaluation results: clinical isolate has not yet been received from the customer. Evaluation conclusions: clinical isolate testing is pending. Overall oxacillin performance of dried pos panels is acceptable.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2006-00052
MDR Report Key786602
Report Source05
Date Received2006-11-15
Date of Report2006-10-24
Date of Event2006-10-24
Date Mfgr Received2006-10-24
Device Manufacturer Date2006-06-01
Date Added to Maude2006-11-28
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 FDA3
Event Location0
Manufacturer ContactJOSE UNTALAN
Manufacturer Street2040 ENTERPRISE BLVD.
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163743285
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDRIED POS COMBO TYPE 21
Generic NameANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS.
Product CodeLTT
Date Received2006-11-15
Model NumberNA
Catalog NumberB1017-201
Lot Number2007-08-18
ID NumberNA
Device Expiration Date2007-08-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key774380
ManufacturerDADE BEHRING, INC.
Manufacturer Address2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US
Baseline Brand NameMICROSCAN
Baseline Generic NameANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
Baseline Catalog NoB1017-201
Baseline Device FamilyANTIMICROBIAL SUSCEPTIBILITY TEST PANEL: DRIED GRAM POS
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK862140
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2006-11-15

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