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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1726926
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher than expected vitros amon results were obtained from a non-vitros quality control fluid when processed on two vitros 5600 integrated chemistry systems. A definitive assignable cause could not be confirmed. Historical quality control results indicate a precision issue. There was no definitive evidence to rule out or confirm the vitros 5600 system contributed to the event. In addition, it is unknown how the customer handled the quality control fluids; therefore, an unexpected vitros 5600 system or fluid handling issue could not be ruled out as contributors to the event.
 
Event Description
A customer contacted the ortho clinical diagnostics (ortho) technical support center (tsc) to report higher than expected amon results obtained when processing non-vitros quality control fluids processed on two different vitros 5600 systems. Vitros 5600 system j1, mas lot aa2105m, vitros amon results 336. 6 and 286. 5 ug/dl versus the expected vitros amon result 238. 2 ug/dl. Vitros 5600 system j2, mas lot aa2105m, vitros amon results 281. 2 and 327. 1 ug/dl versus the expected vitros amon result 232. 6 ug/dl. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected vitros amon results were obtained when processing a quality control fluid on two vitros 5600 systems. Ortho was not made aware of any allegation of patient harm as a result of this event. However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. This report is number 2 of 2 mdr¿s for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS AMON SLIDES
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
513 technology blvd.
rochester NY 14652
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key9218715
MDR Text Key214620677
Report Number1319809-2019-00109
Device Sequence Number1
Product Code JID
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2020
Device Catalogue Number1726926
Device Lot Number1018-0252-8342
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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