MICROFAST 5J J1016-83

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 2014-01-17 for MICROFAST 5J J1016-83 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[18363114] A customer complaint was received for s. Agalactiae isolate with susceptible results for clarithromycin and levofloxacin using a walkaway but visually were resistant. Results could not be confirmed as the isolate was not sent to siemens by the customer. Panels were visual verified and correct results were reported to the physician. There was no adverse impact to pt treatment. Siemens conducted a field correction, internal number (b)(4), fda number z-1272-2013 on march 6, 2013, for false skipped wells and false susceptible misreads with s. Agalactiae affecting multiple antimicrobial agents on microscan microstrep plus type 5 panels ((b)(4)), microfast type 5j panels ((b)(4)) and microfast type 7j panels ((b)(4)). The customer letter stated results should be visually verified for s. Agalactiae isolates on the above panel types. A review of complaints associated with this field correction determined a mdr was needed.
Patient Sequence No: 1, Text Type: D, B5


[18666918] Evaluation: method (3367) use testing. Results: definition - discrepant results between visual and instrument interpretations. Conclusion: design deficiency - discrepant results between visual and instrument interpretations.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2014-00008
MDR Report Key3704686
Report Source05
Date Received2014-01-17
Date of Report2013-01-21
Date of Event2013-01-16
Date Mfgr Received2013-01-21
Device Manufacturer Date2012-10-01
Date Added to Maude2014-05-02
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 ContactLESLIE ARDIZONE
Manufacturer Street2040 ENTERPRISE BLVD.
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163743075
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-1272-2013
Event Type3
Type of Report3

Device Details

Brand NameMICROFAST 5J
Generic NameMICROFAST 5J
Product CodeLTT
Date Received2014-01-17
Model NumberNA
Catalog NumberJ1016-83
Lot Number2013-10-29
ID NumberNA
Device Expiration Date2013-10-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US 95691


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-17

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