MAUDE Adverse Event Report: IMMUCOR, INC. PANOCELL-20; REAGENT RED BLOOD CELLS

Catalog Number	0005020
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e1053 reagent red blood cell donor was erroneously noted on the 14231 panel master list labeling as being antigen v positive, whose presence was determined by immucor using only a single example of a specific antibody.Based on a confluence of lack of antisera availability, the immucor laboratory performed a dhr review to confrim the v antigen status prior to the product release to market.The dhr review concluded that bulk manufacturing testing was done using red blood cells from the bulk material, which showed that cell number eleven (11), e1053, resulted v antigen positive at 2+ strength of reactivity.Additionally, all other specifications were deemed to be acceptable, and the product was therefore subsequently released to market.
Event or Problem Description
On (b)(6) 2018, an immucor employee visiting a customer site, reported on behalf of that customer site an unexpectedly negative result outcome by test tube method, using panocell-20, when tested on (b)(6) 2018.

• Brand Name: PANOCELL-20
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7560979
• Report Number: 1034569-2018-00135
• Device Sequence Number: 2044192
• Product Code: KSZ
• UDI-Device Identifier: 10888234001843
• UDI-Public: 10888234001843
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 06/08/2018
• Device Catalogue Number: 0005020
• Device Lot Number: 14231
• 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: 05/15/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR