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

Catalog Number	0004802
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on 05oct2017 and 10oct2017 which performed as expected.
Event or Problem Description
On 03oct2017, it was determined that a (b)(6) customer report received on 11sep2017 of an unexpected positive result when using anti-m (murine monoclonal) gamma-clone by manual test tube method, was reportable.

• Brand Name: ANTI-M (MURINE MONOCLONAL) GAMMA-CLONE
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6988138
• Report Number: 1034569-2017-00291
• Device Sequence Number: 1549570
• Product Code: KSZ
• UDI-Device Identifier: 10888234000464
• UDI-Public: 10888234000464
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: 10/12/2018
• Device Catalogue Number: 0004802
• Device Lot Number: 993017
• 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: 09/11/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR