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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 Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher than expected vitros chemistry products amon slide lot 1018-0254-0463 results were obtained from biorad lot 54320 quality control fluids on a vitros 5600 integrated system. The assignable cause of the event was not determined. A review of quality control performance prior to the event indicated the amon accuracy was higher than peer and there was some imprecision observed. However, the magnitude of suboptimal qc precision and accuracy observed with historical qc was not similar to the significant shift in accuracy and precision that the customer observed for the time interval in question. Therefore, a vitros amon lot 1018-0254-0463 issue was not a likely contributing factor but could not be completely ruled out. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon slides lot 1018-0254-0463. The customer did not do any of the troubleshooting recommendations provided by ortho but instead discontinued running vitros amon for approximately 3 weeks. The customer began qc testing again and acceptable performance has been maintained. Ortho was unable to further investigate how the issue was resolved as the customer declined to further follow up. Therefore, the assignable cause of the event was not determined. An instrument issue as well as qc handling & storage could not be ruled out as potential contributing factors to this event. (b)(4).
 
Event Description
The customer reported that higher than expected vitros chemistry products amon slide lot 1018-0254-0463 results were obtained from biorad lot 54320 quality control fluids on a vitros 5600 integrated system. Biorad level 2
=
99. 3, 103. 9, 120. 4, 113. 2, 131. 4, 123. 9, 155. 2 versus expected 82. 5 umol/l. Biorad level 3
=
296. 6, 280. 6, 306. 9, 289. 4, 324. 9, 334. 4 versus expected 227. 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. There were no erroneous amon patient results reported from the laboratory. However, the investigation cannot conclude that patient results would be not affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number 9 of 13 mdr¿s for this event. Thirteen (13) 3500a forms are being submitted for this event as 13 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
100 indigo creek drive
rochester NY 14626
Manufacturer Contact
joseph falvo
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key10875194
MDR Text Key252875131
Report Number1319809-2020-00146
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 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2021
Device Catalogue Number1726926
Device Lot Number1018-0254-0463
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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