NEG BREAKPOINT COMBO 47 B1017-417

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 NEG BREAKPOINT COMBO 47 B1017-417 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[22141182] A customer complaint was received for qc holding for 42 hours when previously results were available earlier. Results were not duplicated by siemens. It is unknown if treatment was delayed or withheld. There are no reports of adverse health consequences associated with the discrepant results. Siemens conducted a field correction, internal number (b)(4), fda number z-1525-2013 on "may 3, 201", for out-of-range quality control results for qc p. Aeruginosa atcc 27853 vs. Arg or false negative arg results with clinical isolates if the panels pass qc testing. In addition, 42 hour identification panel hold may occur due to a weak arg reaction on the neg breakpoint combo 47, b1017-417 panels, lot number 2013-11-13. The customer letter stated any remaining inventory should be discarded. A review of complaints associated with this field correction determined a mdr was required.
Patient Sequence No: 1, Text Type: D, B5


[22215679] Method: actual device not evaluated - retention samples tested. Results: no results available since no evaluation performed. Retention samples tested. Conclusion: device not returned - retention samples testing did not duplicate the results.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2014-00012
MDR Report Key3704603
Report Source05
Date Received2014-01-17
Date of Report2013-02-22
Date of Event2013-02-19
Date Mfgr Received2013-02-22
Device Manufacturer Date2012-11-01
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-1525-2013
Event Type3
Type of Report3

Device Details

Brand NameNEG BREAKPOINT COMBO 47
Generic NameNEG BREAKPOINT COMBO 47
Product CodeLTT
Date Received2014-01-17
Model NumberNA
Catalog NumberB1017-417
Lot Number11/13/2013
ID NumberNA
Device Expiration Date2013-11-13
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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