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

Catalog Number 1707801

Device Problem Low Test Results (2458)

Patient Problem Test Result (2695)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The investigation determined that a non-reproducible, lower than expected reportable result was obtained from multiple patient samples on a vitros 5,1 fs chemistry system.The most likely assignable cause for this event could not be determined.Based on historic quality control results, there was no indication that vitros glu slide lot: 0048-0968-2345 malfunctioned.Based on acceptable quality control results, there was no indication the vitros 5,1 chemistry system malfunctioned.Since two different vitros 5,1 fs systems were affected by the issue, it is unlikely an instrument related issue contributed to the event.However, a review of data log files indicated the opportunity to optimize the affected vitros 5,1fs system.Since no pre-service diagnostic precision testing was performed prior to optimization of the vitros analyzer, an instrument related issue cannot be entirely ruled out as contributing to the event.Finally, improper pre-analytical sample processing cannot be ruled out as contributing to the event.The sample was not centrifuged according to the sample collection device manufacturer¿s specifications, and it is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a non-reproducible, lower than expected glucose result obtained from a patient sample using vitros clinical chemistry products glucose (glu) slides when tested on a vitros 5,1 fs chemistry system.Patient 2 sample: a vitros glu result of 2.3 mmol/l vs.The repeat result of 11.0 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 lower than expected vitros glu result was not reported outside the laboratory, and there was no 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 GLU 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10741948
• MDR Text Key: 219195158
• Report Number: 1319809-2020-00135
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 10/27/2020

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: 02/01/2021
• Device Catalogue Number: 1707801
• Device Lot Number: 0048-0968-2345
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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