MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D (SERIES 4) MONOCLONAL BLEND; BLOOD GROUPING REAGENT

Catalog Number	0006413
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(4) 2018 to assess the instrument test well images in question, which appeared as visually negative.An immucor field service engineer (fse) visited the customer site on 06feb2018 to assess the instrument used for testing.The fse determined that y-belt tension was too high and it was therefore adjusted, and also the robot camera y and x positions were optimized.The echo instrument is subsequently performing as expected with the exception of the camera module ability to appropriately identify some true positive results.The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instrument.The immucor laboratory tested retention product on 05feb2018, which performed as expected.The immucor laboratory also tested returned blood samples from the customer site on (b)(6) 2018 (pre-transfusion sample (b)(6) and post-transfusion sample (b)(6)), both of which yielded expected rh (d) positive outcomes.Therefore the immucor laboratory was not able to reproduce the customer's observation of unexpected negative reactivity with the post-transfusion blood sample.Testing of these returned blood samples from the customer site was performed with retention product.The internal immucor number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly negative outcome with anti-d (series 4) monoclonal blend on a galileo echo instrument.

• Brand Name: ANTI-D (SERIES 4) MONOCLONAL BLEND
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7297353
• Report Number: 1034569-2018-00050
• Device Sequence Number: 19051816
• Product Code: KSZ
• UDI-Device Identifier: 10888234002000
• UDI-Public: 10888234002000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 103523/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 02/26/2018

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
• Operator of Device: Medical Technologist
• Device Expiration Date: 05/02/2019
• Device Catalogue Number: 0006413
• Device Lot Number: 504765
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 15