MAUDE Adverse Event Report: IMMUCOR, INC. PANOCELL-10; 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	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot 08157 of panocell-10 expired prior to the customer's report to immucor (expiry was april 27, 2018); therefore investigational product testing could not be performed.No relevant testing was performed while the product was in date.On 01jun2018 a dhr review was performed to confirm the presence e and jkb antigen prior to release to market.The review confirmed the presence of the antigens at the time of release.The product reacted as expected.All other specifications were deemed acceptable by dhr quality.
Event or Problem Description
On 23may2018, a customer site reported an unexpectedly negative result outcome by test tube method, using panocell-10, when tested on (b)(6) 2018.

• Brand Name: PANOCELL-10
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7615196
• Report Number: 1034569-2018-00144
• Device Sequence Number: 13971602
• Product Code: KSZ
• UDI-Device Identifier: 10888234000396
• UDI-Public: 10888234000396
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 04/27/2018
• Device Catalogue Number: 0005020
• Device Lot Number: 08157
• 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: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 88