MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

Catalog Number 6902317

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot, and donor history.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 ortho to report one patient failed to react with cell# 3 of 0.8% resolve a panel lot# vra291 exp:01.06.18 tested on mts igg gel cards; manual gel.Patient had a history of anti-e.Customer reports patient in question, antibody screen initially tested 3+ pos with cell#2 from 0.8% selectogen on provue with same lot of mts igg gel cards.Customer reports routine qc performed on 0.8% resolve panel a in question not affected.Customer reports no patient harm caused due to this event occuring.Issue started on:(b)(6) 2017.Frequency: 1x.Microtubes/wells or cell (donor #) affected: cell#3, methodology used: manual, incubation time (for manual test only): 15 min, reaction grade obtained: neg, customer was expecting: pos.Test repeated: yes, result obtained by repeating:neg, method used to repeat:manual gel.Customer reports no signs of hemolysis in red cell reagents.Customer reports storing and testing mts gel cards and reagents according to ifu.Customer reports performing antibody identification with 0.8% resolve panel a lot#vra291 on homozygous antigen e positove cell#3 that reacted negative.Customer reports the same patient back in (b)(6) 2017 was reported with a positive anti-e antibody.Detail any maintenance failure or maintenance inadequately performed that would be relevant for the issue : up to date.Detail any action that ortho requested to find the cause of the issue ortho discussed with customer to phenotype e antigen on cell#3 from 0.8% resolve panel a lot# vra291 in question.Ortho discussed with customer that patient in question may have be expressing anti-e at subdetectable level this time.Ortho referred and discussed ifu with customer.For antibody detection and identification, different serological methods are optimal for different antibodies and that no single antibody screening or identification method optimally detects all antibodies.In some low ionic strength test systems, certain anti-e and anti-k antibodies have been reported to be nonreactive.Customer content with discussion and requests replacements for the one set of 0.8% resolve panel a.Ortho will process replacement and email customer certificate of destruction, customer agreed.

• Brand Name: REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A
• Type of Device: REAGENT RED BLOOD CELLS
• 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: 7185548
• MDR Text Key: 97905780
• Report Number: 2250051-2018-00008
• 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: 01/12/2018

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: 01/06/2018
• Device Catalogue Number: 6902317
• Device Lot Number: VRA291
• Other Device ID Number: 10758750007677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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