MICROSCAN PROMPT INOCULATION SYSTEM-D B1026-10D

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 2006-09-29 for MICROSCAN PROMPT INOCULATION SYSTEM-D B1026-10D manufactured by Dade Behring, Inc..

Event Text Entries

[654466] Account reported to dade behring that they have observed insufficient growth (no results) on microscan dried overnight gram-positive and gram-negative panel type. Report was associated with only the identified prompt lot. No report of injury or illness associated with this issue.
Patient Sequence No: 1, Text Type: D, B5


[7977210] Evaluation: performance testing of customer returns and retention samples. Results: in-house testing performed and confirmed insufficient growth issue with customer provided samples and also with retention samples. Conclusion: dade behring has initiated a field correction for this issue and notified customer of the potential for discrepant mic and/or identification results with clinical and qc isolates with the identified prompt inoculation system-d lot.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2006-00032
MDR Report Key868114
Report Source05
Date Received2006-09-29
Date of Report2006-09-20
Date of Event2006-09-20
Date Mfgr Received2006-09-20
Device Manufacturer Date2006-05-01
Date Added to Maude2007-06-21
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
Remedial ActionOT
Previous Use Code3
Removal Correction NumberFCA 000264
Event Type3
Type of Report3

Device Details

Brand NameMICROSCAN PROMPT INOCULATION SYSTEM-D
Generic NamePANEL INOCULATING SUPPLIES
Product CodeJSD
Date Received2006-09-29
Model NumberNA
Catalog NumberB1026-10D
Lot Number20071127
ID NumberNA
Device Expiration Date2007-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key849649
ManufacturerDADE BEHRING, INC.
Manufacturer Address2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-09-29

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