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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2020
Event Type  malfunction  
Event Description
The investigation determined that higher than expected vitros ammonia (amon) results were obtained from a single vitros liquid performance verifier (lpv) i fluid and two different non-vitros biorad control fluids using three different vitros amon slide lots tested on a vitros 350 chemistry system. Vitros amon slide lot 1018-0254-2563: biorad lot 54350 level 3 amon result of 274. 9 umol/l vs. The baseline mean of 220. 0 umol/l. Vitros amon slide lot 1018-0256-9804: biorad lot 54350 level 1 amon result of 100. 1 umol/l vs. The baseline mean of 19. 0 umol/l. Vitros amon slide lot 1018-0256-4628: biorad lot 54350 level 1 amon result of 100. 1 umol/l vs. The baseline mean of 19. 0 umol/l. Vitros lpv i lot u8880 amon result of 106 umol/l vs. The midpoint of the rom value of 49. 2 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. There was no report of affected patient results and there was no allegation of patient harm. This report is number one of three mdr¿s for this event. Three 3500a forms are being submitted for this event as three devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
 
Manufacturer Narrative
The investigation determined that higher than expected vitros ammonia (amon) results were obtained from a single vitros liquid performance verifier (lpv) i fluid and two different non-vitros biorad control fluids using three different vitros amon slide lots tested on a vitros 350 chemistry system. The assignable cause of the high qc results obtained using vitros amon slide lots 1018-0254-2563 and 1018-0256-9804 was unknown as the events occurred in (b)(6) 2020 and (b)(6) 2021. No additional information concerning the events were provided by the customer. The assignable cause of the high qc results obtained using vitros amon slide lot 1018-0256-4628 was determined to be an instrument event related to microslide incubator contamination. Results of within run diagnostic precision testing demonstrated that the vitros 350 chemistry system was not operating as expected at the time of the event. Ortho field service actions included replacing the incubator evaporation caps and the sample metering proboscis and performing all necessary adjustments. Post service diagnostic precision testing results showed acceptable vitros amon performance indicating that service actions resolved the issue. Email address for contact office in field g1 above is (b)(6).
 
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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 Key13429440
MDR Text Key295901129
Report Number1319809-2022-00007
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 02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2022
Device Catalogue Number1726926
Device Lot Number1018-0254-2563
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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