MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ANTI-A,B (MURINE MONOCLONAL BLEND) BIOCLONE

Catalog Number 711520

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot.Based upon the results of this investigation, the reported customer issue was unable to be confirmed.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Report 2 of 2.A customer complained after obtaining what was described as discordant negative reactions for ab(abo3) in abo forward typing for 2 patients in manual tube method.Event dates: (b)(6) 2018.Complainant/complaint reporter: dr.(b)(6) - physician.Reported on: (b)(6) 2018 by dr.(b)(6) to (b)(6) helpdesk.Software version: 2.01.Reagents: ortho biovue system abo-rh cassette lot abe043f expiry date 13 september 2018 (manufactured on 17 december 2017).Ortho biovue system abo-rh cassette lot abe045f expiry date 16 october 2018 (manufactured on 19 january 2018).Ortho biovue system reverse diluent cassette lot rdc033f expiry date 29 november 2018 (manufactured on 4 december 2017).Anti-a (murine monoclonal blend) bioclone for slide, tube and microplate tests lot baa610ax expiry date 1 september 2018 (manufactured on 1 september 2016).Anti-b (murine monoclonal blend) bioclone for slide, tube and microplate tests lot bbb802ax expiry date 19 september 2018 (manufactured on 19 september 2016).Anti-ab (murine monoclonal blend) bioclone for slide, tube and microplate tests lot abb700ax expiry date 10 august 2018 (manufactured on 10 august 2016).Reagent red blood cells affirmagen-4 lot 4a953z expiry date 24 april 2018 (manufactured on 20 february 2018).Patient information: patient 1 is known group a rhd positive and is not known to be on any drugs or immunosuppressive agents.Patient had a termination of pregnancy when she was very young.Patient 1 was tested on (b)(6) 2018.Sample id: (b)(6).Patient 2 is known group a rhd positive and was tested on (b)(6) 2018.Both the patients are adults and were never tested at this hospital and there is no history/transfusion history for these patients.It is not known if the patients have a subtypes.No further detail was provided for the patients.The customer said that on the (b)(6) 2018 they had tested patient 1 (sample id: (b)(6)) for abo-rh testing using ortho biovue system abo-rh cassette lot abe043f and ortho biovue system reverse diluent cassette lot rdc033f in conjunction with their ortho autovue innova analyser and obtained a negative reaction with anti-a(abo1) reagent in the abo-rh cassette whereas the customer was expecting a positive reaction.The reactions obtained for the patient¿s reverse group were as expected for a group a patient (see mxp (b)(4) investigated under qerts (b)(4)).The customer said that on the same day they had repeated the forward group for patient 1 (sample id: (b)(6)) patient 2 (sample id not provided) using ortho bioclone anti-a(abo1), anti-b(abo2) and anti-ab(abo3) in manual tube method and that they had obtained negative reactions with the 3 reagents and the result for the patient¿s forward group was concluded as group o.No further detail was provided (see (b)(4) investigated under qerts (b)(4)).The customer also said that on the (b)(6) 2018 they had tested patient 2 (sample id not provided) for abo-rh testing using ortho biovue system abo-rh cassette lot abe045f and ortho biovue system reverse diluent cassette (lot not provided) in conjunction with their ortho autovue innova analyser and that they obtained group o rhd positive test result in the forward group which was not as expected whereas, they obtained a group a result in the reverse group which was as expected.No further detail was provided for this patient (see (b)(4) investigated under qerts (b)(4)).The customer also said that on one of the above patients¿ they performed a crossmatch test to establish the correct group and that the patient tested had an incompatible result with donor blood group b.No further detail provided (see (b)(4) and (b)(4) investigated under qerts (b)(4)).The customer said that they would arrange to undertake further testing (a subgroups) for both patients.The customer said that no biased result had been reported to a physician and that the patients concerned had not been harmed as a result of the reported events.

• Brand Name: ANTI-A,B (MURINE MONOCLONAL BLEND) BIOCLONE
• Type of Device: ANTI-A,B
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7490733
• MDR Text Key: 108162747
• Report Number: 2250051-2018-00048
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/10/2018
• Device Catalogue Number: 711520
• Device Lot Number: ABB700AX
• Other Device ID Number: 10758750003129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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