MAUDE Adverse Event Report: BECKMAN COULTER, INC. HEMOCCULT SENSA SINGLE SLIDE WITH DEVELOPER AND APPLICATORS; REAGENT, OCCULT BLOOD

Model Number 64151

Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2021

Event Type  malfunction  

Event Description

Hemoccult card with patient sample on it was sent to lab for analysis.The lab rejected the sample because the lot number and expiration date was not printed on the card by the manufacturer.Lab/nursing went thru the cards stored in ed and lab and found one additional card with no lot number or expiration date stamped on it.

• Brand Name: HEMOCCULT SENSA SINGLE SLIDE WITH DEVELOPER AND APPLICATORS
• Type of Device: REAGENT, OCCULT BLOOD
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 12216831
• MDR Text Key: 263132496
• Report Number: 12216831
• Device Sequence Number: 1
• Product Code: KHE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2021

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
• Device Operator: No Information
• Device Model Number: 64151
• Device Catalogue Number: 64151
• Device Lot Number: 50512 2L
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1