MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN CALIBRATORS; IN-VITRO DIAGNOSTIC

Catalog Number 6801043

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/21/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected, vitros myog results were obtained from a non-vitros quality control fluid when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined.The most likely assignable cause for the lower than expected qc fluid results is a sub optimal calibration event.In addition, an instrument maintenance issue may have contributed to the event as the customer had not performed cleaning of the microwell incubator as per the recommended schedule.

Event Description

A customer obtained lower than expected vitros myoglobin (myog) results when processing a non-vitros quality control fluid on a vitros 5600 integrated system.Biorad level 1 lot 29861 vitros myog results 55.052*, 56.154*,45.488*, and 52.546* ng/ml versus the baseline mean 66.39 ng/ml.A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The lower than expected, vitros myog results were obtained when processing a quality control fluid.Ortho was not made aware of any allegation of patient harm as a result of this event.However the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.(b)(4).

Manufacturer Narrative

The actual product impacted by this event is the vitros immunodiagnostics products myoglobin calibrators, not the vitros immunodiagnostic products myoglobin reagent pack.Therefore, the brand name, common device name, catalogue # and unique device identifier have been corrected.Investigation into the root cause is still in progress, but the issue is linked to the stability of the vitros myoglobin calibrators post reconstitution by the user.Ortho has issued field action with the following instructions to the end user.Reconstitute the calibrators using 1.0 ml distilled water, as per current instructions.Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) discard reconstituted calibrators after 4 hours.Ortho notified the fda¿s (b)(6) of this field action on 30 november 2018.

Event Description

This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN CALIBRATORS
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 7282173
• MDR Text Key: 100894344
• Report Number: 3007111389-2018-00018
• Device Sequence Number: 1
• Product Code: JIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2018
• Device Catalogue Number: 6801043
• Device Lot Number: 1280
• Other Device ID Number: 10758750001019
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1