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

Catalog Number 6901939

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot.All results were satisfactory.Sample was requested but not returned to ortho for further investigation.(b)(4).

Event Description

Customer contacted tsc to report patient rh typing discrepancy using anti-d bioclone lot# db311a exp.2/25/18.Customer states that in march, patient was tested using tube method with this lot# and result obtained was abo type o negative at immediate spin, no weak d testing performed.Patient returned in may, second patient sample tested with another lot of anti-d bioclone, result obtained was abo type o positive, with the rh type yielding a 1+ result at immediate spin.Issue started on: (b)(6) 2017 (exact date not provided at this time), frequency: isolated, sample id: patient sample.Methodology used: tube testing.Incubation time (for manual test only): no weak d testing performed, only is.Pattern observed: discrepant result.Reaction grade obtained: negative with first sample, positive 1+ with second sample.Customer was expecting: consistent results.Test repeated: no.Customer states that all reagents used for testing passed quality control.Visual inspection of reagents and sample ok.No weak d (du) testing performed in (b)(6) with first sample.Customer's facility sop does not require weak d testing for negative rh type.No previous history of patient, no known transfusion history.Tsc obtained pertinent complaint information.Tsc discussed possible reasons for discrepancy in results, including cell suspension differences, two different samples tested, 1+ weak result as opposed to strong reaction observed.Tsc discussed ifu for anti-d bioclone with customer, discussed clones used for testing.Tsc and customer agreed to obtain sample back for further testing since customer wants to verify that both lots of anti-d bioclone should have picked up the 1+ result.Tsc will generate rga activity and proceed with investigation.Tsc will obtain sample for further testing and investigation.Unable to obtain sample since customer had already discarded it.

• Brand Name: ORTHO BLOOD GROUPING REAGENT ANTI-D (ANTI-RHO) BIOCLONE
• Type of Device: BLOOD GROUPING REAGENT
• 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: 6677230
• MDR Text Key: 78960375
• Report Number: 2250051-2017-00054
• 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: 06/29/2017

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: 02/25/2018
• Device Catalogue Number: 6901939
• Device Lot Number: DB311A
• Other Device ID Number: 10758750007455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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