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

Catalog Number 1882208

Device Problem High Test Results (2457)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros glucose (glu) results were obtained from a vitros performance verifier (pv) processed using vitros chemistry products glu slides lot 0004-3209-8824 on a vitros 5,1 fs chemistry system - refurbished.The assignable cause of the higher than expected results is suboptimal calibrations likely caused by the customer not following ortho recommended protocol for preparation of the vitros calibrator kit.The customer was not allowing an adequate warm up period before preparing the vitros cal kit 1 and calibrating the vitros glu reagent.After vitros cal kit 1 lot 0178 was prepared using the proper protocol, an optimal calibration was obtained for vitros glu and post calibration qc results returned to within expectations.There is no evidence that the vitros 5,1 fs chemistry system or the vitros glu reagent malfunctioned.(b)(4).

Event Description

The customer reported that higher than expected vitros glucose (glu) results were obtained from a vitros performance verifier (pv) processed using vitros chemistry products glu slides lot 0004-3209-8824 on a vitros 5,1 fs chemistry system - refurbished.Vitros pvii q7692 results of 32.650, 32.104, 31.248, 32.148 and 33.141 mmol/l vs the expected result of 16.63 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected qc results were not reported from the laboratory.However, the investigation cannot conclude that patient sample results were not or would not be 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 1 of 2 mdr¿s for this event.(2) 3500a forms are being submitted for this event as two devices were involved.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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10926932
• MDR Text Key: 252296416
• Report Number: 1319808-2020-00042
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 12/01/2020

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: 03/22/2021
• Device Catalogue Number: 1882208
• Device Lot Number: 0178
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/01/2020
• Date Device Manufactured: 03/22/2019
• 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