MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID EXTEND II; REAGENT RED BLOOD CELLS

Catalog Number	0006457
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An immucor employee visited the customer site on 17jul2017 to retrieve results from an archived disk, and the images of the test wells in question were visually positive.The product had already expired at the time of this investigation, so the immucor laboratory performed a dhr review of this product on 15mar2018 which showed that all specifications were deemed to have been acceptable.
Event or Problem Description
On 13mar2018, it was retrospectively determined that a component of a (b)(6) customer site report from (b)(6) 2017, made by an immucor employee when that employee happened to be visiting the customer site, which was previously reported under (b)(4) required an additional report for an unexpected negative antibody identification with capture-r ready-id extend ii when tested with a galileo echo instrument.

• Brand Name: CAPTURE-R READY-ID EXTEND II
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7403078
• Report Number: 1034569-2018-00087
• Device Sequence Number: 13462517
• Product Code: KSZ
• UDI-Device Identifier: 10888234000693
• UDI-Public: 10888234000693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/5030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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: 08/22/2017
• Device Catalogue Number: 0006457
• Device Lot Number: DN101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR