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

Catalog Number 6801042

Device Problem Low Test Results (2458)

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

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that multiple lower than expected myog quality control results were obtained using a single non-vitros quality control level in combination with a vitros 5600 integrated system.The investigation could not determine a definitive assignable cause.A within run vitros tt4 marker precision test, used to assess instrument function, was not performed, therefore the vitros 5600 system could not be entirely ruled out as a contributing factor.Based on historical quality control results, a vitros myog reagent performance issue is not a likely contributor to the event, however the possibility that an unexpected vitros myog reagent performance issue or a pre-analytical sample handling issue contributing to the results could not be entirely ruled out.A definitive assignable cause for the event could not be determined.

Event Description

The customer observed multiple lower than expected vitros myog results obtained from a single non-vitros biorad quality control fluid processed on a vitros 5600 integrated system.Biorad l5 control results of 110.773, 107.156, 116.864, 114.667, 113.300, 115.402, 115.048, 109.252, 111.79, and 115.014 ng/ml versus customer established baseline mean 127.95 ng/ml.A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples.Ortho has not been made aware of any erroneous vitros myog patient results obtained or reported from the laboratory over the time frame of the 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.There was no reported allegation of patient harm as a result of this event.This report is number two of two 3500a forms filed for this event, as two devices were affected.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK
• 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; 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: 5854542
• MDR Text Key: 52767272
• Report Number: 3007111389-2016-00141
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2016
• Device Catalogue Number: 6801042
• Device Lot Number: 1100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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