VITROS CHEMISTRY PRODUCTS PHBR SLIDES 8221384

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 2013-02-21 for VITROS CHEMISTRY PRODUCTS PHBR SLIDES 8221384 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[3140144] The customer obtained multiple, non-reproducible, unexpected vitros phbr quality control results using a vitros 5,1 fs chemistry system. Qc fluid lot k1912 = 13. 29, 13. 40, 13. 96, 14. 19, 13. 29 vs. Expected result = 10. 15 ng/ml;qc fluid lot q2098 = 42. 11, 49. 25, 47. 51, 48. 26 vs. An expected result= 61. 71 ng/ml;biased results of the direction and magnitude observed may lead to inappropriate physician action if they were to occur undetected on patient samples. No vitros phbr patient samples were questioned during the time frame of the event. There was no report of patient harm as a result of this event. This report is number nine of nine mdr's for this event. Nine 3500a forms are being submitted for this event as nine devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[10538245] The investigation confirmed that multiple, non-reproducible, unexpected vitros phbr quality control results were predicted while using the vitros 5,1 fs chemistry system. There is no evidence that an instrument related issue contributed to the event. The investigation is yet to confirm that expected performance was achieved using an alternate reagent lot. The investigation was unable to determine a definitive root cause at the time of this report. However, the most likely cause of this event is a reagent related issue. Additional investigation by ocd regarding vitros phbr reagent performance is ongoing.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319809-2013-00094
MDR Report Key2972233
Report Source05
Date Received2013-02-21
Date of Report2013-02-21
Date of Event2013-01-09
Date Mfgr Received2013-01-23
Device Manufacturer Date2012-03-26
Date Added to Maude2013-05-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. JOSEPH FALVO
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO-CLINICAL DIAGNOSTICS
Manufacturer Street513 TECHNOLOGY BLVD.
Manufacturer CityROCHESTER NY 14652
Manufacturer CountryUS
Manufacturer Postal Code14652
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS PHBR SLIDES
Generic NameIN-VITRO DIAGNOSTICS
Product CodeDLZ
Date Received2013-02-21
Catalog Number8221384
Lot Number2538-0060-8974
Device Expiration Date2013-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-21

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