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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher than expected vitros amon results were obtained when the customer processed a non-vitros biorad quality control (qc) fluid using vitros amon lot 1018-0255-4508 on a vitros 5600 integrated system. The assignable cause of the event cannot be determined with the information provided. Historical qc for vitros amon lot 1018-0255-4508 was unacceptable, however a complaint review for vitros amon lot 1018-0255-4508 indicated only one additional complaint that was resolved by service actions. Continual tracking and trending does not indicate a systemic issue with vitros amon lot 1018-0255-4508. A diagnostic vitros amon precision test was requested by the tsc but not completed by the customer at the time of this report. Therefore, an issue with the vitros 5600 integrated system cannot be ruled out as a contributor to the event. Email address for contact office is (b)(6).
 
Event Description
The investigation determined that higher than expected vitros ammonia (amon) results were obtained when the customer processed a non-vitros biorad quality control (qc) fluid using vitros amon lot 1018-0255-4508 on a vitros 5600 integrated system. Biorad lot 54302 vitros amon results of 108. 4, 104. 4, 108. 9, 118. 5, 92. 1, 99. 5 and 90. 4 umol/l versus the baseline mean of 74. 76 umol/l. The customer obtained the lower than expected result when processing a non-patient fluid. There was no indication patient results were affected around the time of the event. However, the investigation could not rule out patient samples would not be affected if the event were to recur undetected. Ortho was not made aware of any allegation of patient harm as a result of this event. This report is number five of seven mdr¿s for this event. Seven 3500a forms are being submitted for this event as seven devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and ivd (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
laurie o'riordan
1295 southwest 29th avenue
pompano beach, FL 33069
9549709500
MDR Report Key11812991
MDR Text Key276226562
Report Number1319809-2021-00081
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 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2022
Device Catalogue Number1726926
Device Lot Number1018-0255-4508
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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