MAUDE Adverse Event Report: BECKMAN COULTER, INC. HEMOCCULT; REAGENT, OCCULT BLOOD

Model Number 395067

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2021

Event Type  malfunction  

Event Description

The lab received a stool sample that was obviously bloody and contained many blood clots.When lab staff member tested this sample for occult blood the result initially was negative for blood even though the internal qc on the hemoccult card worked.The staff member knew something was wrong and opened a new developer bottle on 1/12 and retested patient sample that was positive for blood, result was released to patient emr.We did some experimentation and repeated the same bloody stool sample from yesterday with the reagent just opened yesterday, and today the result is very weak positive.There seems to clearly be a stability or degradation issue even though reagents do not outdate for some time.

• Brand Name: HEMOCCULT
• Type of Device: REAGENT, OCCULT BLOOD
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 11243145
• MDR Text Key: 229108747
• Report Number: 11243145
• 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: 01/22/2021

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: Other
• Device Model Number: 395067
• Device Catalogue Number: 395067
• Device Lot Number: 0102 2L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 106