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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 Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation concluded that lower than expected ammonia (amon) results were obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1018-0253-3401 on a vitros 250 chemistry system. The cause of the lower than expected quality control (qc) results is unknown as the customer did not perform any requested troubleshooting to aid in the investigation of the event. Therefore, improper fluid handling or an instrument related issue due to incubator contamination cannot be ruled out as potential causes of the event. An issue with vitros amon lot 1018-0253-3401 cannot be ruled out as it was a new lot of reagent that the customer was attempting to put into use at the time of the event and there were no historical qc results to evaluate. However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1018-0253-3401.
 
Event Description
A customer reported lower than expected ammonia (amon) results obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides on a vitros 250 chemistry system. Vitros lpv ii lot j6667 results of 147, 136 and 142 umol/l versus the expected result of 186. 8 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected results were obtained when processing a quality control fluid. The customer did not process any patient samples. There was no allegation of patient harm as a result of this event. This report is number 2 of 3 mdr¿s for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved. This report corresponds to ortho clinical diagnostics inc. (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 Key10188675
MDR Text Key225941698
Report Number1319809-2020-00065
Device Sequence Number1
Product Code JID
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 06/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2021
Device Catalogue Number1726926
Device Lot Number1018-0253-3401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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