MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO OPTIX READER MTS; SEMI-AUTOMATED CARD READER

Model Number	6842222
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).On (b)(6) 2022, a customer complained to ortho care about what was described as a discordant blood group results for donors samples using their ortho optix reader mts.Complainant/ complaint reporter name: (b)(6).Laboratory supervisor date of events: (b)(6) 2022 donor¿s information: six donor units that were expected to be o pos.The customer reported that on (b)(6) 2022 they had tested six donor samples for retyping in abo using mts technology in manual method with automatic reading on their ortho optix reader mts and that they had obtained two units correctly retyped, however the other 4 units were typed as b pos.The customer repeated testing on the four samples that typed as b pos.The customer obtained a result of o pos for two of the samples and b pos for the other two.The customer once again repeated testing on the two samples that repeated as b pos and this time obtained the correct result of o pos.The customer reported that no biased result was reported to a physician.The customer reported that no patient/donor had been harmed as a result of the reported events.Investigation details: the customer reported that they had processed qc samples the day of the events and that the results were not initially as expected.After running them again they were passed.On (b)(6) 2022, ortho care followed with the customer and provided the following information on the reported occurrences.The customer had indicated that this concern has been resolved and was not the fault of the ortho optix reader mts.The customer had indicated that the concern was due to either user error in pipetting, carryover or potentially bad diluent causing false positive results to the anti-b well to some of these tests.The customer reports all testing was repeated by their senior technologist and all results were satisfactory.The customer is in the process of retraining the original tester.The customer indicates their confidence that the listed ortho products and the ortho optix reader mts are performing as expected.No incorrect or erroneous results have been reported because of this reported concern.The customer has agreed to contact tsc if any additional concern arise.The assignable cause of the discordant abo blood group results for the donor's samples is linked to a user error.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics device and reagents to perform as intended.No further complaints of this type have been received from the customer site since the time of the reported events.Summary: discordant abo blood group results for donor samples using mts technology with their ortho optix reader mts.The assignable cause is user error related.No general product failure is identified.No biased result was reported to the physician.No patient/donor was harmed.
Additional Manufacturer Narrative
Investigation details: the customer reported that they had processed qc samples the day of the events and that the results were not initially as expected.After running them again they were passed.On (b)(6) 2022, ortho care followed with the customer and provided the following information on the reported occurrences.The customer had indicated that this concern has been resolved and was not the fault of the ortho optix reader mts.The customer had indicated that the concern was due to either user error in pipetting, carryover or potentially bad diluent causing false positive results to the anti-b well to some of these tests.The customer reports all testing was repeated by their senior technologist and all results were satisfactory.The customer is in the process of retraining the original tester.The customer indicates their confidence that the listed ortho products and the ortho optix reader mts are performing as expected.No incorrect or erroneous results have been reported because of this reported concern.The customer has agreed to contact tsc if any additional concern arise.The assignable cause of the discordant abo blood group results for the donor's samples is linked to a user error.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics device and reagents to perform as intended.No further complaints of this type have been received from the customer site since the time of the reported events.Summary discordant abo blood group results for donor samples using mts technology with their ortho optix reader mts.The assignable cause is user error related.No general product failure is identified.No biased result was reported to the physician.No patient/donor was harmed.

• Brand Name: ORTHO OPTIX READER MTS
• Common Device Name: SEMI-AUTOMATED CARD READER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16112543
• Report Number: 0002250051-2023-00002
• Device Sequence Number: 17603925
• Product Code: KSZ
• UDI-Device Identifier: 10758750032846
• UDI-Public: 10758750032846
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6842222
• Device Catalogue Number: 6842222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown