MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN VITRO DIAGNOSTICS

Catalog Number 1882208

Device Problem Low Test Results (2458)

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

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a lower than expected calcium result was obtained from a non-vitros biorad quality control (qc) fluid using vitros chemistry products ca slides lot 0345-0601-1498 on a vitros 5600 integrated system.The assignable cause of the event is due to a suboptimal calibration.The cause of the suboptimal calibration is unknown.The result was obtained on a calibration that was determined to have atypical parameters when compared to expected database values.When the calibration with acceptable parameters was restored, acceptable results were obtained for the biorad qc and patient sample repeat results.The customer confirmed that they are following the instructions for use for calibration preparation, therefore improper protocol is not a likely cause of the suboptimal calibration.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a lower than expected calcium (ca) result obtained from a non-vitros biorad quality control (qc) fluid using vitros chemistry products ca slides on a vitros 5600 integrated system.Biorad 56442 vitros ca result of 9.94 mg/dl vs the baseline mean of 13.2 mg/dl based results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.No results were reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10648596
• MDR Text Key: 246419551
• Report Number: 1319808-2020-00040
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Catalogue Number: 1882208
• Device Lot Number: 0190
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1