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

Catalog Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 12/09/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation concludes that a lower than expected vitros crea result was obtained from a single patient sample tested on a vitros 5600 integrated system.The assignable cause of this event is unknown.There is no indication of a systemic reagent issue.The issue is isolated to a single slide.An instrument related issue cannot be ruled out as a contributing factor.Service actions were completed to replace the dispense blade, although, it could not be confirmed if the service actions were related to the lower than expected result.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as the customer is not adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

The customer obtained a non-reproducible, lower than expected vitros crea result from a single patient sample tested on a vitros 5600 integrated system.Patient result of <0.25 mg/dl versus the expected result of 1.84 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The lower than expected result was reported outside the laboratory, however, the result was questioned by the physician.A corrected report was sent to the physician and there was no allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA 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: 7143616
• MDR Text Key: 96128617
• Report Number: 1319809-2017-00196
• Device Sequence Number: 1
• Product Code: JFY
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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: 6802584
• Device Lot Number: 1512-3465-9829
• Other Device ID Number: 10758750002849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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