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

Catalog Number 8157596

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 09/03/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros k+ results were obtained from two different quality control fluids (vitros performance verifier lot n5113 and non vitros biorad quality control fluid lot 31812) when run on a vitros 350 chemistry system.The most likely assignable cause was related to sub-optimal calibration events.It is possible the customer did not follow proper protocol when changing to a new lot of erf and the lower than expected results may be attributed to the user error.There is no indication of a reagent issue.The same k+ slide lot (lot 4102-0976-2241) was performing as expected on another vitros instrument in the customer's laboratory suggesting the issue was isolated to a single instrument.An instrument issue cannot be completely ruled out as a contributing factor.A within run k+ precision test was not completed successfully.

Event Description

A customer observed higher and lower than expected potassium (k+) results from two different quality control fluids when run on a vitros 350 chemistry system.Vitros k+ results for vitros performance verifier (lot n5113) 5.2, 5.1, 5.2, 5.1, 5.2, 5.2, 5.1, 5.2, 5.2, 5.2, 5.1, 5.1, 5.2, 5.1, 5.2, 5.2, 5.2, 5.2 and 5.1 mmol/l versus the center of the range of means of 2.84 mmol/l.Vitros k+ result for non-vitros biorad quality control fluid (lot 31812) 4.90 mmol/l versus the customer¿s baseline mean of 6.36 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The higher and lower than expected k+ results were obtained when testing quality control fluids.The customer made no allegations that patient samples were affected and there were no reported allegations of actual patient harm as a result of this event.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers 1938075 / qerts record id 414637.

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6900629
• MDR Text Key: 89499495
• Report Number: 1319809-2017-00176
• Device Sequence Number: 1
• Product Code: CEM
• 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: 09/28/2017

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: 12/01/2018
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-0976-2241
• Other Device ID Number: 10758750010233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2017
• Initial Date FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1