MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN-VITRO DIAGNOSTIC

Catalog Number 1662659

Device Problem Low Test Results (2458)

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

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros sodium (na+) results were obtained from a single non-vitros biorad level 3 quality control (qc) fluid, lot 45800, using vitros na+ slides on a vitros 5600 integrated system.The event was isolated to the calibration event performed on (b)(6) 2018.The most likely cause of the suboptimal (b)(6) 2018 calibrations was user error, where improper reconstitution of calibrators occurred.The customer visually observed the reconstituted calibrator vials and stated the volumes were not consistent, vial to vial.In addition, the customer used a cura socorex 3 ml pipette, which uses disposable pipette tips.The customer stated it is possible the tips used to reconstitute the (b)(6) 2018 calibrator fluids were not secured properly onto the cura pipette, which could lead to an improper volume of diluent being added to the lyophilate.Acceptable vitros na+ performance was observed after a calibration event was performed using properly handled calibrator fluids.The investigation found no indication the vitros 5600 integrated system or vitros na+ slide lot 4220-1001-4323 contributed to the event.

Event Description

A customer obtained lower than expected vitros sodium (na+) results from a single non-vitros biorad level 3 quality control (qc) fluid, lot 45800, using vitros na+ slides on a vitros 5600 integrated system.Biorad l3 na+ results of 133.2 and 131.7 mmol/l vs.The expected result of 165.0 mmol/l biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros na+ results were generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8185586
• MDR Text Key: 131910445
• Report Number: 1319808-2018-00049
• Device Sequence Number: 1
• Product Code: JIX
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1662659
• Device Lot Number: 0288
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2018
• 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