MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-C MONOCLONAL GAMMA CLONE; REAGENT RED BLOOD CELLS

Catalog Number	0066421
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Test Result (2695)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes malfunction event.A review of the event indicated that one (1) patient sample test using anti-c monoclonal gamma clone antisera on an automated blood bank system produced a false positive result in manual tube.Subsequent testing and prior testing showed the patient was negative for anti-c.Through post event tests and investigations, no specific causes was determined for the malfunction.

• Brand Name: ANTI-C MONOCLONAL GAMMA CLONE
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 10016382
• Report Number: 1034569-2020-00037
• Device Sequence Number: 14232297
• Product Code: QHT
• UDI-Device Identifier: 10888234001355
• UDI-Public: 10888234001355
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 103498/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0066421
• Device Lot Number: 936200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1