MAUDE Adverse Event Report: IMMUCOR, INC. IMMULINK; SOFTWARE, BLOOD BANK, STAND ALONE

Catalog Number 0064327

Device Problems Computer Software Problem (1112); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

An immucor specialist employee assessed the software in question on (b)(6) 2018 and confirmed that the date of birth demographic information is indeed carried over from the previous sample, but the immucor specialist employee was able to establish that no other demographic information is carried over.To clarify, this issue happens when a sample that does not have patient demographics is scanned into the qiacube worklist in immulink software following a sample that does have patient demographics.(b)(4).

Event Description

On (b)(6) 2018, a customer site reported a label generated from immulink software that contained the wrong patient demographic information.

• Brand Name: IMMULINK
• Type of Device: SOFTWARE, BLOOD BANK, STAND ALONE
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 7348974
• MDR Text Key: 103273309
• Report Number: 1034569-2018-00071
• Device Sequence Number: 1
• Product Code: MMH
• UDI-Device Identifier: 10888234001034
• UDI-Public: 10888234001034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: 0064327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1