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, donor history, and donor complaint review.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 reports one event where a patient sample containing anti-big e and anti-small c failed to react with the small c positive cells (#4,5,7,8,9,10) from resolve panel a of lot vra291 exp 1/16/18 in anti-igg gel cards.The patient's anti-big e reacted with cell#s 3 and 6 which had the big e and small c antigens.Customer was unable to identify anti-c.Customer performed additional investigations when two crossmatches were performed with big e negative donors yet the results were incompatible.At that time, tube method was done using a competitor's product with an enhancement reagent, the antibody identification revealed that both anti big e and anti-small c were present.Crossmatch testing was repeated with donors that were negative for the big e and small c antigens and the blood units were crossmatch compatible as expected.At the request of tsc, the cells in question (#s 4,5,7,8,9,10) were antigen typed for the small c antigen and the results were 3+ to 4+ strong using ortho bioclone anti-c (small) as per her supervisor, the customer was directed to use these same 3% cell suspensions that were used in the antigen typing test and repeated the antibody identification.The patient's anti-small c antibody reacted positive 1+ with cells 4,7,8,10.Issue started on: (b)(6) 2017.Methodology used: vision.Reaction grade obtained: neg for anti-c.Test repeated: yes see above for details.Qc data: vision qc passed.Patient/sample data: no prior history of having antibodies.Cards storage condition temperature: as per ifu.Visual appearance before use: acceptable.Reagent red blood cell storage and handling: as per ifu.No manual gel methods are performed at this site, vision is working as expected ortho discussed with customer that patient may be expressing anti-small c that is too low in titer to be detected in gel at this time.Ortho reviewed 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." customer expressed understanding and was satisfied with discussion.

• 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: 7189092
• MDR Text Key: 98008047
• Report Number: 2250051-2018-00009
• 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: 01/15/2018

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: 01/16/2018
• 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: 12/22/2017
• Initial Date FDA Received: 01/15/2018
• 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