MAUDE Adverse Event Report: BECKMAN COULTER, INC. 66040 GASTROCCULT TEST FOR GASTRIC OCCULT BLOOD AND PH 40 TEST SLIDES; REAGENT, OCCULT BLOOD

Model Number 66040

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

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

Event Date 06/14/2019

Event Type  malfunction  

Event Description

The ph section on a particular lot of gastrocult slides is reading inaccurately with the buffers we use for quality control.

• Brand Name: 66040 GASTROCCULT TEST FOR GASTRIC OCCULT BLOOD AND PH 40 TEST SLIDES
• Type of Device: REAGENT, OCCULT BLOOD
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 8901021
• MDR Text Key: 154556449
• Report Number: 8901021
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2019

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: 66040
• Device Catalogue Number: 66040
• Device Lot Number: 20581
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1