MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9; IN-VITRO DIAGNOSTIC

Catalog Number 8568040

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that higher than expected vitros phenytoin (phyt) results were obtained from multiple lots of vitros tdm performance verifiers after the initial calibration of vitros phyt slide lot 2617-0167-1501 on a vitros 5,1 fs chemistry system.The likely assignable cause was a sub-optimal calibration.A review of the calibration parameters concluded the intercept and slope were not comparable to all e-connected users on this phyt lot.Recalibration using the same phyt slide cartridge and fresh calibrator fluids resolved the issue.The cause of the sub-optimal calibration could not be determined.However, an issue with iwf (immuno-wash fluid) or calibrator fluid handling cannot be ruled out as a contributing factor to the sub-optimal calibration.A phyt reagent issue is not a likely contributor because recalibration using the same slide cartridge resolved the issue.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros phyt lot 2617-0167-1501.A within-run precision test was not performed to assess the overall performance of the vitros 5,1 fs chemistry system, therefore the vitros 5,1 fs chemistry system cannot be ruled out as a contributing factor.

Event Description

A customer obtained higher than expected vitros phenytoin (phyt) results from multiple lots of vitros tdm performance verifiers after the initial calibration of vitros phyt slide lot :2617-0167-1501 on a vitros 5,1 fs chemistry system.Vitros tdm pvii lot w5156 results 29.67 umol/l and 28.34 umol/l versus the midpoint of the rom 58.2 umol/l.Vitros tdm pviii lot t5896 results 126 umol/l and 127, umol/l versus the midpoint of the rom 100.2 umol/l.Vitros tdm pviii lot x6157 results 132 umol/l and 133, umol/l versus the midpoint of the rom 96.25 umol/l.Vitros tdm pviii (lot unknown) results 59.49, 64.30, 130.94, 136.26, 139.81, 127.96, 124.71, 126.46, 134.89, 138.06, 134.57, 132.79 umol/l versus midpoint of t5896 100.2 umol/l and midpoint x6157 96.25 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if the issue were to occur undetected on patient samples.The higher than expected vitros phyt results were obtained when the customer was processing performance verifier (pv) fluids.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 8139285
• MDR Text Key: 130622135
• Report Number: 1319808-2018-00047
• Device Sequence Number: 1
• Product Code: JIT
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 8568040
• Device Lot Number: 957
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2018
• 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