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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 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation has determined that higher than expected ammonia results were obtained from an american proficiency institute (api) proficiency sample using vitros chemistry products amon reagent lots 1018-0251-7488 and 1018-0252-8342 on a vitros 4600 chemistry system. The sample result was reproducible when tested at an alternate site using vitros amon reagent lot 1018-0253-3823 in combination with a vitros 350 chemistry system. The assignable cause of the event is an issue related to the api sample. The higher than expected sample result was reproducible using multiple lots of vitros amon reagent and on two different vitros instruments from two different customer sites. Based on historical quality control results a vitros amon reagent performance issue is not a likely contributor to the event. Within run precision testing performed on the vitros 4600 chemistry system was within ortho acceptable guidelines. This along with the quality control results data indicate that an issue with the vitros 4600 chemistry system is not a likely contributing factor of the event.
 
Event Description
A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected ammonia results obtained from an american proficiency institute (api) sample using vitros chemistry products amon slides on a vitros 4600 chemistry system. Vitros amon lot 1018-0251-7488 on customer vitros 4600 chemistry system: api sample 1 result of 135* umol/l versus an expected result of 101. 5 umol/l, (b)(6) 2019. Vitros amon lot 1018-0252-8342 on customer vitros 4600 chemistry system: api sample 1 result of 133* umol/l versus an expected result of 101. 5 umol/l, (b)(6) 2019. 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 from an api proficiency sample. The customer indicated that no patient sample results were affected. There have been no allegations of patient harm as a result of this event. 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 Key9510324
MDR Text Key214632293
Report Number1319809-2019-00127
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 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
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 Received11/26/2019
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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