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 Death (1802)

Event Date 02/05/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed batch review, complaint review by lot, donor history, and donor complaint review.All results were satisfactory.Retain testing unable to be performed since customer reported after the expiration of the product.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Report 2 of 2.Customer reporting two separate events of negative reactions with samples later identified with anti-jka related to donor # 4 (donor # (b)(6); homozygous for jka).The first event occurred on (b)(6) 2017 where patient with no previous history was admitted via the er; ( diagnosis = upper gi bleeding, plus cirrhosis of liver).Patient was immediately transfused 4 units of packed red cells; uncross matched.After getting subsequent sample, patient's antibody screen was positive; because of bleeding, patient continued to received uncross matched units (total of 16 units of packed cells that were jka positive.Patient also received plasma products ( total # not provided) later during identification testing of sample using 0.8% resolve panel a lot # vra268, positive reactions were noted with all homozygous jka positive cells except # 4.The reacting homozygous cells showed 1-2+; no reactions were noted with heterozygous jka positive cells.According to customer, due to patient's medical condition, patient expired later on (b)(6) 2017.Customer further added, death of patient was not related to transfusion of uncross match units of packed cells; however, facility felt they needed to inform ocd of event.Customer further added, the site performed jka phenotype on donor #(b)(6) and saw weak 1+ reaction.Second separate event occurred on (b)(6) 2017, where patient had a positive antibody screen.With additional testing using 0.8% resolve panel a lot # vra268, anti-jka was id; but again they saw no reactivity with donor # 4 (jka homozygous cell).Second patient was not transfused, but customer indicated site would transfused jka negative units if required.Issue started on: (b)(6) 2017; reported 3/17/2017.Frequency: 2x.Methodology used: manual gel, incubation time (for manual test only): 15 mins, customer was expecting: positive, test repeated: no.Associated reagent: card/cassette type: mts igg gel card, rbc type: 0.8% selectogen, last qc run: date of use.Cards /cassettes/ storage condition temperature: as per ifu visual appearance before use: ok, pipette used: mts, incubator type: mts, cards/cassettes centrifugation: mts.

• 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: marta carnielli ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 6457889
• MDR Text Key: 72187231
• Report Number: 2250051-2017-00028
• 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: 04/04/2017

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: 02/28/2017
• Device Catalogue Number: 6902317
• Device Lot Number: VRA268
• Other Device ID Number: 10758750007677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• 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