MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D (MONOCLONAL BLEND) GAMMA-CLONE; BLOOD GROUPING REAGENT

Catalog Number	0066420
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The donor facility sent the blood sample to the immucor dx laboratory for rhd genotyping.The immucor dx laboratory determined that the blood donor was actually a d deletion (d variant), which was consistent with the conglomeration of all of the rh (d) testing with all of the different anti-d reagents and clones, which is discussed in the reagent specific instructions for use as limitations.The internal immucor record tracking number was (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpected result when using anti-d (monoclonal blend) gamma-clone by manual test tube method, when tested on (b)(6) 2018.

• Brand Name: ANTI-D (MONOCLONAL BLEND) GAMMA-CLONE
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7428890
• Report Number: 1034569-2018-00094
• Device Sequence Number: 1718869
• Product Code: KSZ
• UDI-Device Identifier: 10888234001348
• UDI-Public: 10888234001348
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: 103629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 12/20/2018
• Device Catalogue Number: 0066420
• Device Lot Number: 506231
• 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: 03/20/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR