MAUDE Adverse Event Report: IMMUCOR, INC. GAMMA-CLONE ANTI-S; ANTI-S BLOOD GROUPING REAGENT

Catalog Number	0066813
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2018, immucor tested gamma-clone anti-s lot 625014 with selected cells from panocell-20 lot 44367.Four s positive and 4 s negative cells were selected.All cells resulted as expected.Controls and retention product performed as expected.On (b)(4)2018, immucor tested gamma-clone anti-s lot 625014 with the returned sample (b)(6).Controls performed as expected and the returned sample resulted negative.On (b)(4) 2018 immucor notified the customer of the following that: "we received sample for investigation.We tested our retention product and your returned sample.The following is a summary of our product investigation laboratory's findings.We tested the returned sample (b)(6) with retention anti-s lot 625014.Controls performed as expected and the returned sample resulted negative.We reproduced your report.The sample submitted is from a patient with sickle cell disease and most likely from african-american decent.Dna information you supplied does not state if the s antigen presents as a variant form of normal s antigens.Therefore by serology, this s antigen may or may not react with some examples of commercial anti-s antisera due to different clones where the antisera are derived.Immucor anti-s monoclonal gammaclone is manufactured from a different clone than bio-rad anti-s.This could account for the unexpected reactivity you observed.Our investigation did not identify a product deficiency, retention products performed as expected." the internal immucor document number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018 a customer reported a typing discrepancy for little s on a patient sample when using gamma-clone anti-s blood grouping reagent.

• Brand Name: GAMMA-CLONE ANTI-S
• Common Device Name: ANTI-S BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8243856
• Report Number: 1034569-2019-00009
• Device Sequence Number: 11292765
• Product Code: KSZ
• UDI-Device Identifier: 10888234002215
• UDI-Public: 10888234002215
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125492/0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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: No Information
• Device Expiration Date: 04/20/2020
• Device Catalogue Number: 0066813
• Device Lot Number: 625014
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1