MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CREA SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 6802584

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible lower than expected vitros creatinine (crea) result was obtained from a single patient sample tested on a vitros 5600 integrated system.The most likely assignable cause of the event is unknown.A sample related issue cannot be completely ruled out as it is unknown if the customer was following the sample collection device manufacturer recommendations for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.In addition, the sample viscosity decreased between the initial and repeat test events, which would likely occur if debris were present in the sample.Pre-analytical sample mix-up could neither be ruled out or confirmed as the cause of the event.The final z step should decrease with each test as the sample volume decreases.The final z step increased with the retest event, which should have had less sample volume than the initial test event, not more.This indicates the potential for pre-analytical sample mix-up.However, if the customer had added sample from an additional sample collected at the same collection event as sample 1, or from a second sample collected from the same patient, then the final z steps could potentially increase with a second test event.The customer did not respond when asked to confirm if the same sample was used for both sample 1 test events, therefore, pre-analytical sample mix-up could not be confirmed.Historic vitros crea quality control results were acceptable within the timeframe of the event, indicating that vitros crea slide lot: 1531-3512-0423 was performing as intended on the vitros 5600 system.A performance issue with the vitros 5600 system did not likely contribute to the event.The customer stated this issue was isolated to this specific event, which indicated it is unlikely the vitros 5600 system malfunctioned.However, since no diagnostic within-run precision testing was performed to assess instrument performance, the vitros 5600 system cannot be completely rued out as contributing to the event.Email address for contact office in field mfr site above is (b)(6).

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a non-reproducible, lower than expected result obtained from a single patient sample using the vitros chemistry products creatinine (crea) slides on a vitros 5600 integrated system.Patient sample 1 crea result of 0.64 mg/dl vs.The expected result of 5.57 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros crea result was reported outside of the laboratory, however, the result was questioned and no treatment was given, changed, or withheld based on the reported vitros crea result.A corrected report was issued and there was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-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 Key: 15051849
• MDR Text Key: 304183414
• Report Number: 1319809-2022-00044
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 6802584
• Device Lot Number: 1531-3512-0423
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1