MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE P INDICATOR RED CELLS; REAGENT RED BLOOD CELLS

Model Number	0066240
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction events.A review of the events indicated that one (1) patient sample test using capture-p indicator cells reagent on an automated blood bank system produced an unexpected negatives with capture p ready screen due to a defective dropper dispensing too much reagent.The original testing was performed using the dropper inside of the indicator cell vial and 1 drop was used.On the repeat testing the customer used a calibrated pipettor with exactly 50 ul and a positive result was received.The error was caused by the customer's incorrect testing methods.The result represented a false negative based on prior patient history.Subsequent testing of the retention lot showed acceptable results.Through post event tests and investigations, no other specific causes were determined as a cause of the malfunction.

• Brand Name: CAPTURE P INDICATOR RED CELLS
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 10016365
• Report Number: 1034569-2020-00028
• Device Sequence Number: 2462178
• Product Code: QHT
• UDI-Device Identifier: 10888234001256
• UDI-Public: 10888234001256
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK860017/1
• 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 Model Number: 0066240
• Device Catalogue Number: 0066240
• Device Lot Number: A055,226437
• 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