MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO BLOOD GROUPING REAGENT ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE; ANTI-A BIOCLONE

Catalog Number 711328

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot.All results were satisfactory.(b)(4).

Event Description

Two of 4: anti-a (murine monoclonal blend) bioclone for slide, tube and microplate tests lot baa613ax expiry date 21 june 2019.Sample tested on (b)(6) 2018.The customer is reporting discordant positive a(abo1) and b(abo2) antigen typing results for one patient¿s samples using the ortho bioclone reagents in manual tube method.Complainant / complaint reporter: dr.(b)(6) ¿ laboratory manager.Event date: (b)(6) 2018.Reported on: (b)(6) 2018 by dr.(b)(6) to ortho care helpdesk.Reagents: anti-a (murine monoclonal blend) bioclone for slide, tube and microplate tests lot baa613ax expiry date 21 june 2019.Anti-b (murine monoclonal blend) bioclone for slide, tube and microplate tests lot bbb804ax expiry date 30 march 2019.Anti-d (rh1) igm+igg bioclone lot 7428 expiry date 7 march 2019.Patient information: female patient born on (b)(6) and is trying to get pregnant.The patient is on vitamins, folic acid, cardioaspirin and other products to stimulate fertility.The patient has no transfusion history at the hospital site; and had no known transplants.The customer reported that, on (b)(6) 2018 they had tested a sample from patient for forward grouping using ortho bioclone anti-a(abo1), anti-b(abo2) and anti-d(rh1) in manual tube method and that they had obtained positive reactions with the 3 reagents.The customer also said that they do not perform reverse group on patients.The customer reported the result for the patient as ab rhd positive.No further detail was provided.The customer said that, on (b)(6) 2018 they had repeated the forward group for the same patient using 2 different samples by 2 different technicians using ortho bioclone anti-a(abo1), anti-b(abo2) and anti-d(rh1) in manual tube method and that they had obtained positive reactions with the 3 reagents again and the result for the patient was concluded as ab rhd positive.It is not known whether the customer reported the result to the physician on this occasion.No further detail was provided.The customer said that the patient came back to the laboratory and said that she has previously been grouped as o rhd positive.In addition, on (b)(6) 2018 the patient was grouped as o rhd positive by another laboratory - (b)(6).The customer also said that on (b)(6) 2018 patient reported having a blood test in (b)(6) where she also reported the issue she experienced with her previous tests to the laboratory.It was also reported that in this laboratory for the forward group there was little agglutination and that they warmed the sample as they found that the patient had cryoglobulins prior to testing.The laboratory also reported that there was no issue with the reverse group.The laboratory reported the group for the patient as o rhd positive.The customer said that when they received the reports from the patient¿s blood test in (b)(6), they repeated the procedure by warming the sample and by washing the cells twice to remove any interference in the serum and that they obtained the result for the patient as o rhd positive.No further detail was provided.The customer said that a biased result was reported to the physician.The patient was not harmed as a result of the reported events.

• Brand Name: ORTHO BLOOD GROUPING REAGENT ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE
• Type of Device: ANTI-A BIOCLONE
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7371304
• MDR Text Key: 103942634
• Report Number: 2250051-2018-00032
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2019
• Device Catalogue Number: 711328
• Device Lot Number: BAA613AX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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