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

Catalog Number 8157596

Device Problem Low Test Results (2458)

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

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros k+ results were obtained from a vitros quality control sample when processed on a vitros 5600 integrated system.A definitive assignable cause was not identified; however, two separate sub-optimal calibration events are the most likely contributing factors.An unexpected vitros instrument issue cannot be ruled as contributing to the event, as no within-run precision testing was performed to verify the system.A definitive assignable cause to the event cannot be identified.

Event Description

Multiple lower than expected vitros k+ results were obtained from a vitros performance verifier (pv) fluid sample (lot k4852) when processed on a vitros 5600 integrated system.The following results breached vitros k+ potential health and safety criteria: vitros pv ii vitros k+ results of 4.77, 4.76, 4.86, 4.70, 4.74, 4.72 4.69 4.70 4.73 and 4.70 mmol/l versus the expected result of 5.60 mmol/l.Biased results of the direction and magnitude observed could lead to inappropriate physician action if the event were to occur with patient samples.There were no reports that unexpected patient sample results were reported outside the laboratory.However, the investigation cannot conclude that patient sample results were not affected and 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 three of ten 3500a forms filed for this event, as ten devices were affected.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ 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: 6633120
• MDR Text Key: 77628032
• Report Number: 1319809-2017-00086
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 06/12/2017

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: 09/01/2018
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-0969-9743
• Other Device ID Number: 10758750010233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1