MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO 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 04/13/2018

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

Event 2 of 3.Customer contacted tsc to report two different patients were typed with anti-d bioclone reagent lot# db319a exp: 8.24.2019 in tube method and both patients typed as o neg on initial draw.Customer did not perform weak d testing and resulted o neg.Abo rh retype draw was performed on second sample and they saw a weak-1+ pos with anti-d bioclone reagent lot# db319a a different tech performed typing on the initial sample with the same anti-d bioclone reagent lot# db319a and obtained a weak- 1+ reaction third tech performed abo rh typing on initial sample and neg results observed.Customer reports no harm came to either patient as no transfusion occured and no history of transfusion.Customer reports qc passed using lot# cnf107 exp: 5.8.2018.Issue started on: has occured twice in past month frequency: 2 different patients.Methodology used: manual tube.Incubation time (for manual test only):immediate spin.Pattern observed: neg.Reaction grade obtained: neg.Customer was expecting: pos.Test repeated: yes.Result obtained by repeating: weak-1+.Method used to repeat: manual tube.Customer report no signs of contamination in anti-d bioclone.Customer reports storing product according to ifu.Customer reports both patients were adult males.Customer reports anitbody screening on patients in question is negative.Customer tested with different techs with discrepant results between them.Customer performed weak d testing to further investigate and both patients 2+ pos reaction.Detail any maintenance failure or maintenance inadequately performed that would be relevant for the issue : up to date.Tsc discussed with customer how 3% to 5% suspension is being prepared.Tsc discussed with customer that suspension may be too light not exposing enough red cell antigens to anti-d in bioclone.Tsc emailed customer certificate of destruction and ifu of anti-d bioclone.Customer did not perform molecular testing on patient samples in question.Customer will review red cell suspension preparation with techs.Customer content with documentation of event, no further action from tsc.

• Brand Name: ORTHO 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: 7452291
• MDR Text Key: 107103094
• Report Number: 2250051-2018-00042
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2018

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: 10758750003662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 04/23/2018
• 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