MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE; ANTISERA

Catalog Number 6901939

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/01/2006

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

Customer contacted tsc to report single patient reacted 1+ pos in tube method with forward anti-d bioclone reagent lot# db319a exp: 8.24.2019.After further incubation for weak d testing, patient sample in question resulted in 2+ pos.Patient typed as o pos but customer will leave patient results as o neg.Customer reports two previous times patient in question was typed as o neg, with same tube methodology, customer claims using anti-d bioclone but, lot number from two previous times unknown by customer.Customer reports qc passed successfully using ortho confidence system lot# cnf104 exp: 4.10.2018.Issue started on: 2006 first sample- patient typed as o neg.On 02.11.2017 second sample- patient typed as o neg.On 03.16.2017 third sample - patient typed as o po.Frequency: 1x.Methodology used: tube method incubation time (for manual test only): immediate spin.Pattern observed: pos.Reaction grade obtained:1+ pos, after weak d incubation period 2+ pos.Customer was expecting: neg.Test repeated: yes, but with same sample.Result obtained by repeating: same.Method used to repeat: manual tube.Customer reports storing and testing anti-d bioclone according to ifu.Customer reports patient is (b)(6) year old female patient, not pregnant and medication and medical history not provided.Customer reports patient in question, last known transfusion in 2006.Customer reports last two times patient was typed in 2006 and 2017 weak d testing was performed and found to be weak d negative.Customer reports following procedure outlined in ifu.Detail any maintenance failure or maintenance inadequately performed : up to date.Tsc requested lot number of anti-d bioclone used in previous typings that occured in 2006 and 2017 customer reports she does not have lot numbers.Customer reports current patient sample tested for direct antiglobulin test and found to be neg.Tsc discussed with customer red cell suspension when patient was first typed for anti-d may have possibly been a weak suspension not allowing enough antigen sites to create complex with anti-d bioclone in 2006 and 2017.Customer content with documentation of event and will monitor and call back if further information becomes available.

• Brand Name: ORORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE
• Type of Device: ANTISERA
• 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: 7431876
• MDR Text Key: 106148342
• Report Number: 2250051-2018-00037
• Device Sequence Number: 1
• Product Code: KSZ
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 04/15/2018

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?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/24/2019
• Device Catalogue Number: 6901939
• Device Lot Number: DB319A
• Other Device ID Number: 10758750007455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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