MAUDE Adverse Event Report: IMMUCOR, INC. CSW100 WASHING SYSTEM; MICROPLATE WASHER

Catalog Number 0005175

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

We are unable to rule out the issue being related to the technique and or handling of the testing on the manual capture by the customer.

Event Description

Customer reported obtaining unexpected negative (compatible) crossmatch results for a patient sample containing anti-jkb.

• Brand Name: CSW100 WASHING SYSTEM
• Type of Device: MICROPLATE WASHER
• 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: 5057819
• MDR Text Key: 25140747
• Report Number: 1034569-2015-00130
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: 0005175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2009
• 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
• Patient Age: 60 YR
• Patient Weight: 61