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

Catalog Number 6801042

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that a lower than expected vitros myoglobin (myog) result was obtained from a cliniqa quality control (qc) fluid processed using vitros myog reagent in combination with a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause.However, a possible cause for the lower than expected qc fluid result is a suboptimal calibration event.Qc performance improved after another calibration event was executed.In addition, per a customer communication issued 28 november 2018, calibrators must be left out for a minimum of two hours following reconstitution prior to calibrating.Because the customer could not confirm this protocol was initially followed, pre-analytical fluid handling cannot be ruled out as a cause of this event.The vitros 5600 integrated system was performing as intended and did not likely contribute to the event as within-run precision testing performed by the customer was within acceptable guidelines.Additionally, a reagent issue is not a likely cause of the event as a different vitros 5600 integrated system is running as expected when using the same vitros myog reagent lot.Furthermore, continual tracking and trending of complaints has not identified any signals that show a potential systemic issue with vitros myog reagent lot 1390.

Event Description

A customer reported a lower than expected result from a cliniqa quality control (qc) fluid obtained using vitros immunodiagnostics products myoglobin (myog) reagent on a vitros 5600 integrated system.Cliniqa lot 1804042 (l1) vitros myog result of 51.5 ng/ml vs an expected result of 65.1 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The unexpected vitros myog result was generated from a qc fluid.However, the investigation could not conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8313163
• MDR Text Key: 138166854
• Report Number: 3007111389-2019-00025
• Device Sequence Number: 1
• Product Code: DDR
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2019
• Device Catalogue Number: 6801042
• Device Lot Number: 1390
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2018
• 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